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Chronic bronchitis protocol A MULTICENTRIC OPEN CLINICAL TRIAL TO EVOLVE A GROUP OF EFFICACIOUS HOMOEOPATHIC MEDICINES IN ‘SIMPLE AND MUCOPURULENT CHRONIC BRONCHITIS’ WITH REGARD TO IMPROVEMENT IN THE SYMPTOM COMPLEX OF ‘SIMPLE AND MUCOPURULENT CHRONIC BRONCHITIS’ PROTOCOL TEAM COORDINATORS including programme officers & investigators I. CHIEF CO-ORDINATOR: PROF C. NAYAK , DIRECTOR, CCRH, New Delhi. II.CO-CHIEF CO-ORDINATORS: 1. Dr. Vikram Singh, Assistant Director, CCRH, New Delhi. 2. Dr. Hari Singh, Research Officer, CCRH, New Delhi. III. CO-ORDINATOR: Dr. (Mrs.) Jaya Gupta, Research Officer, CCRH, New Delhi. IV. PROGRAMME OFFICERS/ INVESTIGATORS City Site Centre Programme code Officer a Guwahati RI Regional Dr S. K. 05 Research Sharma Institute b Puri RI Regional Dr. B. K. 04 Research Mondal Institute c Kottayam CI Central Dr. T.N.S. 01 Research Kurup Institute d Chennai CU Clinical Dr. K.S.V. 01 Research Unit Bharathalaxmi e Bhopal CE 01 f Pondicherr y g Tirupati Investigator(s) consultant Dr S. K. Sharma medicine Dr. B. K. Mondal medicine Dr.S. Gopinathan medicine Dr. K. Raju medicine Dr. D.D Arya Dr. P.S. Chakravorty medicine CU 15 Clinical Research cum Epidemic Cell Clinical Research Unit Dr. S. Bhuvneshwari Dr. Prakash Rao medicine CU 04 Clinical Research Unit Dr. G.Ravi Chandra Reddy Dr. R.V. R. Prasad medicine BUDGET: Expenditure will be met by CCRH, New Delhi. 1 Chronic bronchitis protocol 1. INTRODUCTION 1.1 Literature review Chronic bronchitis is a condition associated with excessive tracheobronchial mucus production sufficient to cause cough with expectoration for at least 3 months of the year for more than 2 consecutive years. Simple Chronic bronchitis describes a condition characterized by mucoid sputum production. Chronic mucopurulent bronchitis is characterized by persistent or recurrent purulence of sputum in the absence of localized suppurative diseases such as bronchiectasis. Since there may or may not be obstruction as assessed by the use of the forced expiratory vital capacity maneuver, chronic bronchitis with obstruction deserves a separate classification. Cigarette smoking, air pollution, occupations with exposure to inorganic organic gases, infections and familial and genetic factors contribute to the pathogenesis of chronic bronchitis. The difference between chronic bronchitis with obstruction and asthma is based mainly on the history of the clinical illness. The patient with chronic bronchitis with obstruction has a long history of cough and sputum production with a later onset of wheezing, whereas the asthma patient with chronic obstruction gives a long history of wheezing with later onset of chronic productive cough1 The clinical presentation varies in severity from simple chronic bronchitis without disability to the severely disabled state with chronic respiratory failure. Despite well-planned management, the patient with predominant bronchitis may experience many episodes of respiratory failure from which recovery is frequent with proper therapy 1 CCRH has conducted the study to see the effect of homoeopathic medicine on Bronchitis. The cases which were registered were of Chronic Bronchitis and it is found that homoeopathic medicines have helped in alleviating sign and symptoms of Chronic Bronchitis2 It is apparent that so far no significant work has been done to elicit the efficacy of homoeopathic medicines in chronic bronchitis and that there is no authentic record of homoeopathic medicine(s) for the treatment of the disease, ‘Chronic bronchitis’, in the homoeopathic repertories. As such, there is a need to explore the efficacy of homoeopathic medicines otherwise indicated for the various diagnostic symptoms of chronic bronchitis in the Homoeopathic literature. 1.2. Classification: Chronic bronchitis has been classified in the ICD-10, under item J41, as given below 3 : J41 Simple and mucopurulent chronic bronchitis Excludes : Chronic bronchitis: NOS (J42) Obstructive (J44.-) 2 Chronic bronchitis protocol J41.0 Simple chronic bronchitis J41.1 Mucopurulent chronic bronchitis J41.8 Mixed simple and mucopurulent chronic bronchitis It is also clear from the classification of Chronic lower respiratory diseases (J4047) given in the ICD-10 that the following conditions will be excluded from the purview of the current study: 1.3. Cystic fibrosis (E84.-) Bronchitis, not specified as acute or chronic (J40) Unspecified chronic bronchitis (J42) Emphysema (J42) Other chronic obstructive pulmonary diseases (J44) Asthma (J45) Status asthmaticus (J46) Usefulness: The present study plans to evolve a group of efficacious homoeopathic medicines in chronic bronchitis. It will define the indications of medicines found effective in chronic bronchitis. This will be a valuable data for indexing in the repertory and the same will immensely benefit the profession and the patients, at large. The results of the study will also help in the verification of various clinical/additional symptoms of the medicines. These medicines will provide a gentle, safe and cost effective treatment of the disease. 2. Study Objectives: 2.1 Hypothesis For the open clinical trial, the primary hypothesis is that the use of medicines selected on the basis of repertorisation of the diagnostic signs and symptoms of chronic bronchitis and its characteristic symptoms, in single dose, in a specific potency, would be effective in curing the patient suffering from chronic bronchitis. 2.2. Primary Objective 2.3. To carry out a multicentric open clinical trial of the medicines which will be selected after repertorisation of the diagnostic symptoms of ‘Simple and Mucopurulent Chronic bronchitis’ , to determine therapeutic efficacy of these medicines in Chronic bronchitis, thereby to evluate the efficacy of homoeopathic medicines for Chronic bronchitis. Secondary Objective I. To determine and verify characteristic symptoms of medicine(s) used. 3 Chronic bronchitis protocol II. To check the progression to complications. III. To prevent the relapse. STUDY DESIGN 3 3.1. Type of study It will be an open clinical trial and cases will be enrolled from the General O.P.D. as and when they come till such time that the target is achieved. 3.2 Approach The study is designed to prove or disprove the hypothesis stated above. This is conditional on each study site adhering to the protocol, ensuring quality control and minimizing loss to follow-up to below 5% and is also subject to the fact that the studies continue till adequate sample size, specified below, is recruited. 3.3. Location The following Institutes/Units have been selected for carrying out the research study keeping in view the adequacy of the manpower, facilities of Lab investigations and the willingness of the research personnel at the institute: I. Regional Research Institute, Guwahati (site code- RI 05) II. Regional Research Institute, Puri (site code- RI 04) III. Regional Research Institute, New Delhi (site code- RI 02) IV. Central Research Institute, Kottayam (site code- CI 01) V. Clinical Research Unit, Chennai (site code- CU 01) VI. Clinical Research Unit, Pondicherry (site code- CU 15) VII. Clinical Research Unit, Tirupati 3.4 Duration of Study 4 years and 1month 3.5 (site code- CU 04) (2 years for the study + 2 years for the follow-up + 2months for the preparation of the concluding report.) Flow chart of study design 4 Chronic bronchitis protocol 5 Chronic bronchitis protocol Presence of Patients who present with cough with scanty or copious mucoid and tenacious expectoration for three months or more for at least two consecutive years, Written informed consent Cystic fibrosis (E84.-) Bronchitis, not specified as acute or chronic (J40) Unspecified chronic bronchitis (J42) Emphysema (J42) Other chronic obstructive pulmonary diseases (J44) Asthma (J45) Status asthmaticus (J46) No exclusion Yes, register the case and go for baseline assessment Selection of medicine within the 14 drugs Assess the case after 15 days If no response , go for investigation ,ESR& Xray Assess the case if no improvement Stannum metallicum, Phosphorus, No Exclusion ,treat the case in OPD Arsenicum album, 1. Silicea, 2. Lycopodium 3. Pulsatilla. Calcarea carb, 4. Sulphur, 5. Hepar sulph, Ipecacuanha 6. Bryonia alba, 7. Carbo vegetables, Spongia tosta, Antimonium tartaricum 8. Change the prescription maximum twice from trial drugs. If no response, refer the case. 6 Chronic bronchitis protocol 4. SELECTION AND ENROLMENT OF PATIENTS Patients presenting with constant cough with excessive tracheobronchial mucoid or mucopurulent expectoration for at least 3 months of the year for more than 2 consecutive years will be prescribed pre-selected medicine for a specific period, in a specified potency and posology. The periodic follow-up and assessment of these cases will be made for 2 years, at prescribed intervals. It will depend on the changes observed in the frequency, duration and intensity of the paroxysms of cough, expectoration, dyspnoea and crackles, as also on the changes observed in the PFT and the X-ray chest. Various aspects of the study treatment are highlighted below: Patients presenting with constant cough with excessive tracheobronchial mucoid or mucopurulent expectoration for at least 3 months of the year for more than 2 consecutive years will be prescribed pre-selected medicine for a specific period, in a specified potency and posology. The periodic follow-up and assessment of these cases will be made for 2 years, at prescribed intervals. It will depend on the changes observed in the frequency, duration and intensity of the paroxysms of cough, expectoration, dyspnoea and crackles, as also on the changes observed in the PFT and the X-ray chest. Various aspects of the study treatment are highlighted below: 4.1. Diagnosis: 1,4 4.1.1 Symptoms, 4.1.2 Patients who present with cough with scanty or copious mucoid and tenacious expectoration for three months or more for at least two consecutive years, in absence of a disease that could account for this symptom; Recurrent attacks of productive cough, usually in winter months, with steady increase in severity and duration in successive years until cough is present the year round. Shortness of breath and/or a feeling of tightness in the chest that is worse by exertion or mild physical activity. Signs 4.1.3 Normally resonant Chest percussion note; and on auscultation, coarse ronchi (crackles) and wheezes that change in location and intensity after a deep and productive cough. Investigations: Normal Spirometry: FEV1: > 80% predicted FEV1/FVC > 0.7 Vital capacity, mildly diminished, Maximum expiratory flow rates , invariably low; Roentgenographic (X-ray) features: Thickened bronchial walls manifested by tubular or “tramline” shadows 7 Chronic bronchitis protocol 4.2. A generalized increase in bronchovascular markings. Pathological investigations Haemogram, ESR Sputum for AFB on three consecutive days (to rule out mycobacterium tuberculosis infection). Inclusion criteria: 1. Diagnosed cases of Chronic Bronchitis as mentioned in (4.1) without any complications, from any sex and between 20 and 50 years of age fulfilling the following requirements: 4.3. Willing to participate in the study and willing to come for the follow-up visits for two years at prescribed intervals, Residing within approachable distance from the center, Cases who are not, currently, on any other treatment, including homoeopathy, With cases who have taken any treatment, at least two-weeks’ treatment-free interval should have lapsed before the screening phase. Exclusion criteria: 1. Subjects currently on any other treatment (Homoeopathy or other systems) 2. Subjects who have discontinued treatment less than two weeks before, 3. Chronic bronchitis, NOS(J42) and obstructive(J44) as per ICD 10 4. Subjects suffering from Emphysema, cor Pulmonale, Bronchial asthma, Bronchiectasis, Active pulmonary tuberculosis (open), Cystic fibrosis, Bronchopulmonary mycosis, Central airflow obstruction, Acute bronchitis, Pneumonia, Pulmonary thrombo-embolism, Left ventricular failure, Pulmonary hypertension, Chronic respiratory failure, Spontaneous pneumothorax, Bronchogenic carcinoma. 5. Persons requiring oxygen therapy and hospitalization; 6. Cough due to some other underlying disease. 7. FEV,: < 80% PREDICTED 8. FEV1 / FVC < 0.7 5. STATISTICAL PLAN 5.1. Sample size: 8 Chronic bronchitis protocol 5.2 75 cases per year per centre for two years (keeping also a margin for the drop-out cases) 909 cases will be sufficient to assess outcome of improvement rate of 70% with absolute error of ±5% and with a confidence level of 95%. Statistical analysis 6. 1050 cases will initially be enrolled in the study. data obtained during the study would be analysed using appropriate statistical methods. Procedures for selection of medicine 6.1. Selection of the medicine: The selection of the drugs has been arrived at by repertorising the symptoms due to the Chronic Bronchitis. [2]. The repertorisation was done using the Complete Repertory as the reference book. Considering the fact that the study pertains to the Chronic Bronchitis , the drugs given in the first grade (3 points) followed by those in the second grade (2 points) mentioned against the rubrics “Chest; inflammation; Bronchial tubes” and ‘Chronic cough’ in the Complete Repertory have been short-listed. To further minimize the variables, the specific prescribing symptoms of each of these drugs have also been worked out after repertorisation of all the relevant rubrics. 9 Chronic bronchitis protocol 6.1.1 The signs and symptoms of ‘Chronic Bronchitis’ DEFINITIONS 1,4 : EXAMINATION INVESTIGATIONS Chronic bronchitis is a condition associated with excessive tracheobronchial mucus production sufficient to cause cough with expectoration for at least 3 months of the year for more than 2 consecutive years. The patient with predominant bronchitis is often overweight and cyanotic. There is apparently no apparent distress at rest, the respiratory rate is normal or only slightly increased, and there is no apparent usage of accessory muscles. Spirometry: Normal. FEV1: > 80% predicted FEV1/FVC > 0.7 TLC is often normal A moderate elevation of RV Vital capacity, mildly diminished Maximum expiratory flow rates, invariably low Simple Chronic bronchitis describes a condition characterized by mucoid sputum production. Chest percussion note is normally resonant, and by auscultation one can usually hear coarse ronchi and wheezes that change in location and intensity after a deep and productive cough. Roentgenographic features: 1. Thickened bronchial walls manifested by tubular or “tramline” shadows and 2. A generalized increase in bronchovascul ar markings. Chronic mucopurulent bronchitis is characterized by persistent or recurrent purulence of sputum in the absence of localized suppurative diseases such as bronchiectasis. 10 Chronic bronchitis protocol Chronic obstructive pulmonary disease (COPD) has been defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) as a disease state characterized by airflow limitation that is not fully reversible (http://www.goldcopd.com). COPD includes 1. Emphysema, an anatomically defined condition characterized by destruction and enlargement of the lung alveoli; 2. Chronic bronchitis, a clinically defined condition with chronic cough and phlegm; and 3. Small airways disease, a condition in which small bronchioles are narrowed. COPD is present only if chronic airflow obstruction occurs; chronic bronchitis without chronic airflow obstruction is not included within COPD. The patient with chronic bronchitis with obstruction has a long history of cough and sputum production with a later onset of wheezing, whereas the asthma patient with chronic obstruction gives a long history of wheezing with later onset of chronic productive cough. The patient with predominant bronchitis usually has an impressive history of cough and sputum production for many years with an immodest history of cigarette smoking. Initially the cough is present only in winter months, and the patient is apt to seek medical attention, if at all, only during the more severe of the frequent mucopurulent relapses. Over the years the cough progresses from hibernal to perennial and mucopurulent relapses increase in frequency, duration and severity. After beginning to experience exertional dyspnoea, the patient often seeks medical help and will be found to have a severe degree of obstruction. The development of exertional dyspnoea, often described as increased effort to breathe, heaviness, air hunger, or gasping, can be insidious. History, physical examination, and chest radiographs should be supplemented by tests of lung function performed during a symptomatically stable period. Ideally, complete spirometry, plethysmographic lung volumes, transfer of CO, arterial blood gases, and lung elastic recoil properties should be measured. 11 Chronic bronchitis protocol 6.1.2 Corresponding Rubrics in the Complete Repertory: 5 Symptom Corresponding Rubrics Chronic bronchitis is a condition associated with excessive tracheobronchial mucus production sufficient to cause cough with expectoration for at least 3 months of the year for more than 2 consecutive years. Chest; inflammation; Bronchial tubes Simple Chronic bronchitis describes a condition characterized by mucoid sputum production. Expectoration; mucous Expectoration; copious; chronically Expectoration; copious; paroxysmal cough, after Expectoration; mucous; translucent Expectoration; frothy Expectoration; easy Expectoration; transparent Expectoration, white Expectoration; difficult Chronic mucopurulent bronchitis is characterized by persistent or recurrent purulence of sputum in the absence of localized suppurative diseases such as bronchiectasis. Expectoration; purulent Expectoration; yellow Expectoration; thick Expectoration; lumpy Expectoration; balls, in shape of Chronic bronchitis, a clinically defined condition with chronic cough and phlegm. Cough; chronic Expectoration; constant, almost day and evening The patient with chronic bronchitis with obstruction has a long history of cough and sputum production with a later onset of wheezing, whereas the asthma patient with chronic obstruction gives a long history of wheezing with later onset of chronic productive cough. Expectoration; frequent Respiration; difficult; cough; with 12 Chronic bronchitis protocol The patient with predominant bronchitis usually has an impressive history of cough and sputum production for many years with an immodest history of cigarette smoking. Initially the cough is present only in winter months, and the patient is apt to seek medical attention, if at all, only during the more severe of the frequent mucopurulent relapses. Over the years the cough progresses from hibernal to perennial and mucopurulent relapses increase in frequency, duration and severity. After beginning to experience exertional dyspnoea, the patient often seeks medical help and will be found to have a severe degree of obstruction. Cough, winter Respiration; difficult; exertion, after The development of exertional dyspnoea, often described as increased effort to breathe, heaviness, air hunger, or gasping, can be insidious. The patient with predominant bronchitis is often overweight and cyanotic. There is apparently no apparent distress at rest, the respiratory rate is normal or only slightly increased, and there is no apparent usage of accessory muscles. No rubric taken Chest percussion note is normally resonant, and by auscultation one can usually hear coarse ronchi and wheezes that change in location and intensity after a deep and productive cough. No rubric taken 13 Chronic bronchitis protocol 6.1.3 RUBRICS TAKEN FOR REPERTORISATION:5 1. Chest; inflammation; Bronchial tubes 2. Cough; chronic 3. Expectoration; copious; chronically 4. Cough, winter 5. Expectoration; constant, almost day and evening 6. Expectoration; copious; paroxysmal cough, after 7. Expectoration; frequent 8. Respiration; difficult; cough; with 9. Expectoration; mucous 10. Expectoration; mucous; translucent 11. Expectoration; frothy 12. Expectoration; easy 13. Expectoration; transparent 14. Expectoration, white 15. Expectoration; purulent 16. Expectoration; difficult 17. Expectoration; yellow 18. Expectoration; thick 19. Expectoration; lumpy 20. Expectoration; balls, in shape of 21. Respiration; difficult; exertion, after 14 Chronic bronchitis protocol 19/12 19/11 Carb-v. 17/10 17/9 17/8 16/8 3 3 2 3 2 2 3 3 3 02 0 0 1 2 1 1 0 1 0 0 0 0 2 0 1 2 2 0 03 3 3 3 3 1 0 3 3 0 0 2 3 0 3 3 0 0 0 34/16 30/13 28/14 26/11 24/11 25/12 20/9 18/15 19/10 17/11 15/9 15/7 14/10 14/9 11/7 12/7 12/6 13/7 Chin 20/9 3 Dros. 20/11 2 Spong. 20/12 2 Dulc. 22/11 3 Ant-t 24/18 3 Caust. 25/11 3 Bry 29/14 Ip. 29/14 3 Hep. Phos 34/14 3 Calc. Sil. 35/17 3 Puls. Ars. 36/15 01 Lyc. Stann. 40/18 Sulph. 6.1.4 Repertorisation chart (using Complete Repertory By Roger van Zandvoort: 5 04 2 1 0 0 0 0 0 0 0 1 1 0 1 0 1 0 0 0 05 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 06 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 07 2 0 1 0 1 2 0 1 1 0 0 0 0 0 0 0 0 0 08 3 3 2 3 2 0 1 1 2 3 1 2 3 2 0 1 3 1 09 3 3 3 3 3 3 3 1 3 1 3 3 2 2 3 2 3 3 10 0 3 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 11 0 3 1 2 0 2 1 1 1 1 1 0 1 0 0 0 1 0 12 3 0 1 0 0 2 0 1 1 1 0 0 1 1 1 0 0 0 13 2 2 2 3 0 1 0 1 0 0 1 2 1 0 0 0 0 1 14 2 2 1 3 3 2 2 2 0 1 1 2 1 2 1 2 0 1 15 2 2 3 3 3 2 3 1 1 1 1 0 2 1 1 0 2 3 16 3 2 0 2 2 3 2 1 2 3 1 3 1 0 2 1 1 1 17 3 2 3 3 3 3 3 2 3 1 2 1 0 2 0 2 2 0 18 2 2 3 1 2 2 2 1 3 1 1 2 1 1 2 0 0 0 19 2 2 3 1 1 1 0 1 2 0 1 0 0 1 0 1 0 0 20 3 0 2 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 21 2 3 2 2 3 2 3 2 0 3 0 0 0 2 0 3 0 0 15 Chronic bronchitis protocol 19/11 Carb-v. Spong. 19/12 2 3 3 3 3 2 3 2 0 0 1 2 1 1 0 1 0 0 0 2 0 2 3 3 3 3 3 1 0 3 3 0 0 2 0 3 0 34/16 30/13 28/14 26/11 24/11 25/12 20/9 18/15 19/10 17/11 15/9 14/10 14/9 12/7 17/9 20/11 Ant-t 20/12 2 Bry 22/11 Ip. 24/18 3 Hep. 25/11 Sulph. 29/14 3 Calc. 29/14 3 Puls. 34/14 3 Lyc. 35/17 3 Phos 36/15 3 Sil. 40/18 1 Ars. s.no. Stann. 6.1.5.-useful remedies5 4 2 1 0 0 0 0 0 0 0 1 1 1 0 0 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 6 0 0 0 0 0 0 0 1 0 0 0 0 0 0 7 2 0 1 0 1 2 0 1 1 0 0 0 0 0 8 3 3 2 3 2 0 1 1 2 3 1 3 2 1 9 3 3 3 3 3 3 3 1 3 1 3 2 2 2 10 0 3 1 0 0 0 0 0 0 0 0 0 0 0 11 0 3 1 2 0 2 1 1 1 1 1 1 0 0 12 3 0 1 0 0 2 0 1 1 1 0 1 1 0 13 2 2 2 3 0 1 0 1 0 0 1 1 0 0 14 2 2 1 3 3 2 2 2 0 1 1 1 2 2 15 2 2 3 3 3 2 3 1 1 1 1 2 1 0 16 3 2 0 2 2 3 2 1 2 3 1 1 0 1 17 3 2 3 3 3 3 3 2 3 1 2 0 2 2 18 2 2 3 1 2 2 2 1 3 1 1 1 1 0 19 2 2 3 1 1 1 0 1 2 0 1 0 1 1 20 3 0 2 0 1 0 0 1 0 0 0 0 0 0 21 2 3 2 2 3 2 3 2 0 3 0 0 2 3 16 Chronic bronchitis protocol 6.1.6 Trial medicines The following drugs will be tried during the study: Stannum metallicum, Phosphorus, Calcarea carb, Ipecacuanha Carbo vegetables, Arsenicum album, 2. Lycopodium 4. Sulphur, 6. Bryonia alba, Spongia tosta, 1. Silicea, 3. Pulsatilla. 5. Hepar sulph, 7. Antimonium tartaricum 8. 6.1.7 Prescribing indications of the medicines on trial No. MEDICI RUBRICS NE 01. Stannu m metallic um (40/16) Chest; inflammation; Bronchial tubes Expectoration; copious; chronically Respiration; difficult; cough; with Expectoration; mucous Expectoration; easy Expectoration; difficult Expectoration; yellow Expectoration; balls, in shape of Cough, winter Expectoration; frequent Expectoration; transparent Expectoration, white Expectoration; purulent Expectoration; thick Expectoration; lumpy Respiration; difficult; exertion, after 6 CHARACTERISTIC SYMPTOMS It is especially suited to persons who have long been g rowing feeble. There is increasing weakness, cachexia with : sallow waxy countenance and dark rings under the eyes. Pain begins lightly and increases gradually to the highest point and then gradually declines in the same manner as it appeared. There is GREAT DEBILITY and profound weakness which is the key note of Stannum. It is marked both mentally and bodily. The chest is so weak that she drops into a chair instead of sitting down. Feels weak and faints especially when going downstairs. Can go up well enough. Nausea and vomiting from the odour of cooking food. Empty, sinking all-gone sensation in chest and stomach Sweetish and salty expectoration and taste in mouth. The patient experiences very debilitating sweat after 4 a.m. The patient is sad, despondent, feels like crying all the time, but crying makes her worse. Yellowishness is the nature of 17 Chronic bronchitis protocol discharges. Mentally the patient is very much sad and despondent. Great sadness strong disinclination to talk and a pronounced aversion to the company of men. Continued restlessness with anxiety. Distress of mind ceases as soon as menses begin to flow. Mental symptoms are caused by emotion, fright, etc. 02. Arsenicu m album (37/16) Chest; inflammation; Bronchial tubes Expectoration; copious; chronically Respiration; difficult; cough; with Expectoration; mucous Expectoration; mucous; tanslucent Expectoration; frothy Respiration; difficult; exertion, after Expectoration; transparent Expectoration, white Expectoration; purulent Expectoration; difficult Expectoration; yellow Expectoration; thick Expectoration; lumpy Expectoration; balls, in shape of Cough, winter The patient is lean, thin, debilitated having Hippocratic face dirty and waxy look of the skin . Very fastidious. \wants everything neat, clean and in order. Chilly patient. There is internal chilliness and so the patient craves heat, excepting in outer head. Arsenic patient has GREAT FEAR OF DEATH. Mentally restless, but physically too weak and exhausted to move about. Burning pain relieved by heat except in head. Great prostration is persistently present, sinking of strength out of proportion to a degree of illness. Gastric derangements such as diarrhoea, vomiting, etc., are due to food poisoning from spoiled eggs, fish or meat, decayed food, alcohol, ice cream, etc. Complaints return periodically (usually annually) All discharges are acrid, scanty, putrid, dark and offensive with cadaverous odour Thirst for small quantity of water at short intervals in acute states but in chronic state there is no thirst. Cannot bear the smell or sight of food. 18 Chronic bronchitis protocol All symptoms are aggravated at MID-DAY AND MIDNIGHT. 03. Silicea (35/17) Chest; inflammation; Bronchial tubes Expectoration; copious; chronically Expectoration; mucous Expectoration; purulent Expectoration; yellow Expectoration; thick Expectoration; lumpy Expectoration; balls, in shape of Respiration; difficult; cough; with Expectoration; transparent Respiration; difficult; exertion, after Cough; chronic Expectoration; frequent Expectoration; mucous; tanslucent Expectoration; frothy Expectoration; easy Expectoration; white Very nervous, excitable temperament. Lack of stamina and very much afraid of failure. Very sensitive to all impressions. WANT OF GRIT, both mental and physical. Fixed ideas. Has got pin mania, especially for babies. Thinks of nothing except pins; he fears them, still searches for them and counts and preserves them with great care. Headstrong and obstinate babies who cry when kindly spoken to. Ailments from: Vaccination, suppressed foot-sweat, exposure to draught of air. Chest complaints of stone cutters. Highly Chilly patient. Wraps himself up with warm clothing even in hot summer weather. Every little injury suppurates. Has got a wonderful CONTROL OVER THE SUPPURATIVE PROCESSES, anywhere and everywhere in the body. Constitution which suffers from deficient nutrition from defective assimilation. Very sensitive to all impressions, especially noise and becomes anxious there from. Obstinate constipation; stool hard and knotty. When PARTLY EXPELLED RECEDES BACK. Night-walking. Gets up while asleep, walks about and lies down again – all quite unconsciously. Desire for cold drinks, cold food, ice cream. Wants to be magnetized. Sweat of hands, toes, feet, axillae is VERY OFFENSIVE. 19 Chronic bronchitis protocol Intolerable, sour, carrion-like odour of feet, without perspiration and every evening. 04. Phosph orus (34/14) Chest; inflammation; Bronchial tubes Expectoration; copious; chronically Respiration; difficult; cough; with Expectoration; mucous Expectoration; transparent Expectoration, white Expectoration; purulent Expectoration; yellow Cough; chronic Expectoration; frothy Expectoration; difficult Respiration; difficult; exertion, after Expectoration; thick Expectoration; lumpy Phosphorus is best suited for tall, slender persons with narrow chest. Young people who grow too rapidly and are incline to stoop. Sanguine temperament, possessing quick perception and very sensitive nature; also having bilious, irritable temperament. Chilly patient, its head and stomach crave cold, cold application, cold food and COLD DRINKS. Burning anywhere and everywhere all over the body. Burning in spots along the spine, between the scapulae, of palm and hands, in chest. A weak, empty all gone sensation in head, chest, stomach and entire abdomen. Craving cold thins, ice-creak which agrees; cold water which is thrown up as soon as it gets warm in the stomach. Aversion to tobacco, sweets tea, pudding, coffee and beer. Oversensitiveness. Light, noise, odour, touch, electric changes, thunderstorms. Disinclination to both mental and physical exertion even to study or to converse. Restlessness. Cannot stand still for a moment, with CONSTANT FIDGETY FEELING ALL OVER BODY, especially in evening, at twilight. Restlessness with anxiety. Most of the complaints are aggravated when lying on left side. Swelling of both the eyelids. Mind. The patient is very much apathetic and indifferent to friends and surroundings, unwilling to talk, thinks slowly, moves sluggishly. 20 Chronic bronchitis protocol 05 Lycopod ium (29/14) Chest; inflammation; Bronchial tubes Expectoration, white Expectoration; purulent Respiration; difficult; exertion, after Expectoration; mucous Expectoration; yellow Respiration; difficult; cough; with Expectoration; difficult Expectoration; thick Cough; chronic Expectoration; copious; chronically Expectoration; frequent Expectoration; lumpy Expectoration; balls, in shape of Patient is quite intelligent, but physically weak. There is great fear in darkness. Fear of death when alone. Mental exertion, strong emotion, strong odours, gas vapours, thunderstorm, lightning, loss of vital fluids, exposure to drenching rain, tobacco by washing clothes, having hair cut; excessive use of table salt Patient is tired; Chronic mental fatigue. Dread of appearing in public. Desire to be alone; yet has dread of solitude. Great anticipation: lack of confidence, weakness of memory; confused thoughts; loss of confidence in himself. Easily angered; cannot endure opposition or contradiction. Seeks dispute. Greedy and miserly, malicious, avaricious and pusillanimous; very much sensitive; even cries when thanked. FOR PERSONS INTELLECTUALLY KEEN BUT PHYSICALLY WEAK. Ailments from: Fright, anger, mortification or vexation with reserved displeasure. RIGHT SIDED REMEDY. Suited for deep, chronic, progressive diseases. Nearly all the diseases are WORSE IN THE AFTERNOON 4 TO 8 PM. Sourness of the discharges. Everything tastes sour, e.g. eructation. Heartburn, waterbrash, sour vomiting. Intolerance of cold drinks; craves everything warm. Desire for sweet things: warmfood and drink. Aversion to tobacco, bread, coffee. Canine hunger, but a few mouthfuls fill up to the throat. Acidity, wine and bloating of abdomen, especially the lower 21 Chronic bronchitis protocol abdomen. Red sand in urine. Child cries before urinating. Fan like movement of alaenasi.occuring in cerebral and abdominal complaints. Half open condition of the eyes during sleep. Right foot hot and left cold. Dryness of parts such as vagina and skin especially palms. 06. Pulsatill a (29/14) Chest; inflammation; Bronchial tubes Expectoration; copious; chronically Respiration; difficult; cough; with Expectoration; mucous Expectoration; easy Expectoration; difficult Expectoration; yellow Expectoration; balls, in shape of Cough, winter Expectoration; frequent Expectoration; transparent Expectoration, white Expectoration; purulent Expectoration; thick Expectoration; lumpy Respiration; difficult; exertion, after The patient is mild, gentle, amiable in character, yielding disposition, but sometimes timid too. Changeability of mental conditions runs through the whole drug. Weeping disposition. The patient is always full of tears. So she cannot relate her complaints without weeping. Hypochondriacal moroseness; takes bad side of everything. Consolation: gives her immense comfort and relief. Highly emotional, afraid in the evening, fears to be alone. Fear of darkness and of ghosts. Morbid fear of meeting the opposite sex. Ailments from: Chill getting feet wet; eating fatty and starchy food; ice cream; tea and coffee, abuse of mercury, quinine, sulphur, chamomile, abortion, irregular menses; ovarian and uterine troubles; worm affection in children and indigestion. 07. Calcare a Carb. (26/12) Expectoration; copious; chronically Expectoration; mucous Expectoration; purulent Changeability of symptoms. Chilliness. Thirstlessness. Desire: for open air, fatty food. Disagrees meat, bread, milk and smoking. Aggravation from warm in general and amelioration from cold in general and from open air. Great apprehension, worsening towards evening. Fear of darkness, loss of reason, 22 Chronic bronchitis protocol Expectoration; yellow Respiration; difficult; exertion, after Chest; inflammation; Bronchial tubes Expectoration, white Expectoration; difficult Expectoration; thick Respiration; difficult; cough; with Expectoration; frothy Expectoration; balls, in shape of misfortune, contagious and chronic disease. Fears that she will lose her reason or that people will observe her mental confusion. Very forgetful, confused and low spirited. Dejected and melancholic. Great anguish with palpitation. Restlessness of mind with gloomy mood and anxiety. Peevish, always obstinate and self-willed. Indisposed to all work. Sight mental effort produces heat. Timid and restless, as if an evil was impending over her. Solitude is a burden to her with coldness of face, of hands and feet. Great desire to be magnetized. Ailments from: Defective assimilation, imperfect ossification, suppressed sweat, alcohol, cold moist wind, selfabuse, over lifting, strains, mental strains. Loss of vital fluids, suppressed eruption, suppressed menses, Suppressed foot-sweat, fright, etc. GREAT SENSITIVENESS TO TAKE COLD; CANNOT TOLERATE COLD. Disposed to grow fat. HEAD SWEATS PROFUSELY, WHILE SLEEPING WETTING the pillow far around. Sweat of single parts, Sour Smelling. Coldness in general and the single part. Feels better in every way when constipated. Likes to be magnetized. All discharges smell sour. Longing for eggs, craves undigestible things; has aversion to meat; great longing for fresh air. 08. Sulphur (25/18) Expectoration; copious; chronically Chest; inflammation; Bronchial tubes Expectoration, white Sulphur is especially suited to lean, stoop-shouldered persons who walk and sit stooping, walk stooping like an old man. 23 Chronic bronchitis protocol Expectoration; yellow Respiration; difficult; exertion, after Cough; chronic Expectoration; copious; paroxysmal cough, after Expectoration; frequent Respiration; difficult; cough; with Expectoration; mucous Expectoration; frothy Expectoration; easy Expectoration; transparent Expectoration; purulent Expectoration; difficult Expectoration; thick Expectoration; lumpy Expectoration; balls, in shape of 9. Hepar sulph(25 /12) Chest; inflammation; Bronchial tubes Expectoration; mucous Expectoration; yellow Expectoration; thick Expectoration; frequent Respiration; difficult; cough; with Expectoration; thick Expectoration; lumpy Expectoration; difficult Expectoration frothy Expectoration; easy Expectoration; purulent 10. Ipecacu anha (20/12) Chest; in Chest; inflammation; Bronchial tubes Respiration; difficult; cough; with Expectoration; difficult STANDING IS THE WORSE POSITION FOR A SULPHUR PATIENT. Dirty, filthy look of the body, prone to skin affections have redness of all the external orifices. Patient is very much sensitive to atmospheric changes. He is accepted as a HOT PATIENT. GREAT IRRITABILITY, OVERSENSITIVENESS AND HYPERSENSITIVENESS. Suited to torpid lymphatic constitution, persons with light hair and complexion; muscles are soft and flabby. Irritable temperament: easily excited, slightest cause irritates the patient. Highly chilly patient. Very sensitive to touch. HYPERSENSITIVENESS to touch. Sweat profusely day and night without any relief, which is sour and offensive. Sensation of a splinter, fish bone or plug in throat. All the discharges are very much sour. Aggravation From COLD IN GENERAL, cold air, cold food, uncovering. Amelioration: From WARMTH IN GENERAL; covering from head to foot, from warm food and drink; IN DAMP WET WEATHER. The patient has great CRAVING for sour things, vinegar, wine, acids and strong tasting foods. AVESION to fatty food; dislike for all kinds of nourishment Most of its acute complaints commence with nausea and vomiting or all complaints requiring Ipecac are attended 24 Chronic bronchitis protocol Respiration; difficult; exertion, after Cough, winter Expectoration; mucous Expectoration frothy Expectoration; easy Expectoration, white Expectoration; purulent Expectoration; yellow Expectoration; thick 11. Bryonia (16/13) Chest; inflammation; Bronchial tubes Expectoration; mucous Expectoration; copious; chronically Cough, winter Respiration; difficult; cough; with Expectoration; frothy Expectoration; transparent Expectoration, white Expectoration; purulent Expectoration; difficult Expectoration; yellow Expectoration; thick Expectoration; lumpy more or less with nausea. Nausea constant, continuous and persistent with or without vomiting. Nausea not relieved by vomiting. Thirstlessness runs through the whole drug. Clean tongue, with much saliva, but no thirst. Bright red haemorrhage from natural orifices like nostrils, mouth and especially from uterus. Cold sweat on forehead Desire for sweets and dainties. Tall slender persons having dark hair, dark complexion, and firm muscular fibres. Irritable temperament. Patients are hot; aggravated by warmth in general. Rheumatic and gouty diathesis. All complaints are worse from motion. WITH AMELIORATION BY ABSOLUTE REST AND PRESSURE. It is a very persistent remedy. All complaints develop slowly and have an insidious beginning. Bryonia causes dryness of all the mucus membranes e.g. lips, mouth, nose, respiratory tract, alimentary tract and thereby. Great thirst for large quantity of cold water at long intervals; great appetite, eats varaciously. Stitching pain runs through the whole of Bryonia which is relieved by absolute rest and pressure and by lying on painful side. Dropsical effusion into the serous and synovial membrerane, resulting in pleurisy, rheumatic arthritis etc. Desires for things, which when offered are immediately refused. Oysters, sweets, coffee, cold acid drinks and sour drink. To milk, rich food, fatty and greasy food. Most complaints aggravate in summer and by heat; symptoms aggravate after a meal. There is intolerance of vegetable food. 25 Chronic bronchitis protocol 12. Antim tart (16/11) Chest; inflammation; Bronchial tubes Respiration; difficult; cough; with Cough; chronic Expectoration; mucous Expectoration; purulent Cough, winter Expectoration; frothy Expectoration; easy Expectoration; transparent Expectoration, white Expectoration; difficult Expectoration; thick Nose-bleed when menses should appear; blood-spitting or haemoptysis. Breasts are heavy, of a stony hardness, pale but hard, hot and painful; MUST SUPPORT THEM WITH HAND TO prevent least motion. Mind. The patient is very morose and ill-humoured; exceedingly irritable and inclined to be angry. There are great anxiety and mental depression. Delirium, talks about daily business; worse at night; desires to escape from bed and wants to go home, although the patient is at home. Constant motion of the left arm and leg. Desires for things which are refused when offered. Weakness of mind, as if the would faint. Ailments from - Anger, chagrin, mortification; complaints after taking cold or getting hot in summer; when the days are hot and nights are cold; cold food and drink; from suppression of discharges and skin eruptions. Hydrogenoid constitution . Usually suited for diseases originating from exposure to damp basements or cellars, and after vaccination. There is great accumulation of mucus in air passage which cannot be coughed out, but gives a rattling sound, popularly known as “Death Rattle”. Face become pale, cyanosed and flushed due to circulation of unoxydised blood. Nausea. Vomiting, coldness and prostration run through. IRRESISTIBLE DESIRE TO SLEEP. Craving for apples and acids. Aversion to mild and tobacco. Pneumonia with jaundice. Bad effects of vaccination, when Thuja fails and Silicea. Pustular eruption like small pox is a great symptoms. Mind. Confusion of head with a feeling as if he must sleep. Child 26 Chronic bronchitis protocol 14 Carbo vegetabi lis(20/11 ) Expectoration; copious; chronically Chest; inflammation; Bronchial tubes Respiration; difficult; cough; with Expectoration; mucous Expectoration, white Expectoration; yellow Respiration; difficult; exertion, after Expectoration; easy Expectoration; purulent Expectoration; thick Expectoration; lumpy will not allow ilself to be touched. Bad humour during bronchial catarrh. Apprehension and restlessness during evening. Dread of being left alone. Mental excitement and nervousness. The patient is frightened at night. Vertigo on closing the eyes, when walking and flickering before the eyes. Persons of advanced age, women at turn of life; prematurely old people. Cachetic persons, young or old. The face is puffy, bluish, pale and Hippocratic with cold sweat. Though the body is cold to touch, the patient WANTS constantly ato be FANNED RAPIDLY AND FROM NEAR. HAEMORRHAGIC DIATHESIS. Passive haemorrhage of black or dark blood from every orifice of the body e.g. bleeding from lung, bladder, uterus, stomach, ulcers, etc. resulting from weakened circulation. Haemorrhagic tendency runs through the whole remedy. Exhausted vitality from loss of vital fluid. Surface of the body is COLD TO TOUCH, especially from knee to feet. The pulse is intermittent, thready and imperceptible. Weak Digestion, SIMPLE FOOD DISAGREES causing excessive flatulence; abdomen is full to bursting point especially on the upper part; aggravation from least food and relief from eructation and on passing flatus. In the last stage of any disease with copious cold sweat, cold breath, cold tongue, voice lost, this remedy may save a life. WANTS TO BE FANNED RAPIDLY AND FROM A CLOSE DISTANCE in nearly every complaint. Wants clothing loose around the abdomen. The patient craves, things which makes him sick. Whisky or brandy. 27 Chronic bronchitis protocol Hoarseness aggravated in the evening. Sump toms of imperfect oxidation, resulting from deficient capillary circulation, causing blueness of skin and coldness of extremities. Constant sour and rancid eructation. Slowness of though and weakness of memory, dislikes darkness and fears ghosts. Loss of vital fluid, memory, salt, salted meat or fish from abuse of quinine, especially suppressed chill and fever; bad effects of long ago injury, persons who have never fully recovered from the bad effects of some previous illness. 14. Spongia (14/08) Chest; inflammation; Bronchial tubes Respiration; difficult; exertion, after Cough; chronic Expectoration; mucous Expectoration, white Expectoration; yellow Respiration; difficult; cough; with Expectoration; difficult Expectoration; lumpy Exhaustion and heaviness of the body after slight exertion, with orgasm of blood to chest, face. Anxiety and difficult breathing. Anxiety and fear. Every excitement increases the cough. Great dryness of all airpassages. Hoarseness; larynx dry, burns, constricted. Cough,. Dry barking, croupy; larynx sensitive to touch. Croup; worse, during inspiration and before midnight. Respiration short, panting, difficult; feeling of a plug in larynx. Cough abates after eating or drinking, especially warm drinks. Chest weak; can scarcely talk. Bronchial catarrh, with wheezing, asthmatic cough, worse cold air, with profuse expectoration and suffocation; worse, lying with head low and in hot room. Oppression and heat of chest, with sudden weakness. 28 Chronic bronchitis protocol Selection of Medicine Selection of medicine will be made out of the 14 medicines taken up for clinical trial. The first prescription from amongst these 14 medicines shall be the medicine that fetches the highest value on repertorisation of t he presenting signs and symptoms of the disease and its selection shall be further guided by the characteristic mental/emotional and physical attributes of the patient and concomitant(s), if any. Cases which need medicine(s)other than trial group of medicines will be treated in the general OPD and not included in the study. A separate record of such cases will however be maintained at the center. 6.2.1 In case of chronic state 6.2.1.1 Basis of Selection of Medicine: Selection of medicine will be made out of the 14 trial medicines, to be guided by the totality of presenting signs and symptoms on the basis of ‘Principle of Similia’. A comprehensive case record on the specially evolved case recording proforma will be maintained Form C1. Care will be taken to record the following: Detailed evolution of the complaints. Careful analysis of the characteristic nature of the symptoms First prescription: This will constitute of single dose of indicated medicine in potency 30, 4 pills (size 30), to be taken by the patient on empty stomach, and followed by placebo, next day onwards, three times a day for two weeks. 6.2.1.2 Selection of Potency This will constitute of single dose of indicated medicine in potency 30, to be taken by the patient on empty stomach. 6.2.1.3 Dose Each Dose of indicated medicine will consist of, 4 pills size 30. 6.2.1.4 Repetition Indicated medicine will not be repeated. 29 Chronic bronchitis protocol 6.2.1.5. Follow up (Change of Medicine / Second Prescription) Participants will be followed for assessment as per Form D. Response of the prescription will be assessed and further treatment will be as per following guidelines: A. i. ii. iii. iv. v. In case of amelioration: If improvement continues → Placebo to continue. If improvement stops → Repeat the medicine (first prescription) in the same potency. If no further amelioration occurs even after medicine given in same potency or improvement lasts for a very short period → Give higher potency of same medicine. If amelioration of presenting complaints is accompanied by appearance of old symptoms → continue placebo till the improvement continues. If old symptoms come back to stay → repeat same medicine in same potency and then followed as in (iii) above. In case there is no perceptible improvement after adequate repetition of medicine in different potencies, change of medicine is to be considered B. In case of aggravation: (i) Increase in baseline symptoms a. Short aggravation followed by consistent amelioration (homoeopathic aggravation):→ Continue placebo. b. Aggravation of same symptoms without any relief: If intensity is mild → wait for another week, and if no improvement follows or worsening occurs after one week, change of medicine is to be considered. If intensity is severe → the case to be treated as an acute exacerbation of chronic disease. (ii) Appearance of new symptoms (a) If new symptoms are mild and do not cause much concern to the patient → placebo will be continued for one week. (b) If no improvement follows or worsening occurs after one week → change of medicine is to be considered. (c) If these new symptoms are severe and cause considerable discomfort to patient → change of medicine is to be considered. C. In case of no change after first or subsequent prescriptions: a) In case there is no perceptible change (either worse or better) after 1 week of administration of medicine →one dose of the same medicine to be repeated in higher potency (200 and 1M in succession whenever no response from 200) 4 pills, size no.30, taken over the tongue, followed by placebo for one week. b) In case there is no perceptible improvement after adequate repetition of medicine in different potencies, the investigator must look for any obstacle(s) to cure and steps may be taken to remove them. A record of such advice followed by the patient is to be kept in the case follow up. In case no such obstacle(s) found, change of medicine is to be considered on the same line as mentioned in the footnote. ------------------------------------------------------------------------------------------------------------------If aggravation/ no change still continues, another medicine on the basis of modified picture of the disease is to be considered. In case aggravation continues or no improvement comes up inspite of changing medicine twice, the case is to be closed from study and declared as clinical failure 30 Chronic bronchitis protocol 6.2.2 In case of acute exacerbation of chronic disease or any other acute disease arising during the course of treatment of chronic disease. 6.2.2.1. Basis of Selection of Medicine: Prescription will be based on the characteristic symptoms modified as a consequence of acute disease. The medicine selected will be either a continuation of the pre-selected medicine, or one of the better indicated trial medicine, or a new remedy which may be worked out for acute totality. 6.2.2.2 Selection of Potency: Medicine for the treatment of acute exacerbation shall be given in 6 potency. 6.2.2.3 Dose Each Dose of indicated medicine will consist of, 4 pills size 30. 6.2.2.4 Repetition Indicated medicine will be repeated few minutes to hours depending on the intensity of the symptoms till perceptible change appears (Improvement of signs and symptoms). Appearance of any change will be immediately followed by placebo/ or change in remedy, according to response. 6.2.1.5. Follow up (change of medicine / second prescription) Follow up will be done frequently (at an interval of 1-3 days) depending on the need, till such time the acute condition subsides after judicious treatment. Response of the prescription will be assessed and further treatment will be as per following guidelines: A. In case of amelioration of presenting sign & symptoms: I. If improvement continues → Placebo to continue. II. If improvement stops and case presents with same symptomatology → Repeat the same medicine (first prescription) in the higher potency. i.e. 30 if needed. III. If case presents with different symptomatology → change of medicine; another indicated medicine from amongst Trial Medicines in 6 potency on the same guidelines as for the first prescription. B. In case of aggravation of presenting sign & symptoms: (i) Increase in baseline symptoms a) Short aggravation followed by consistent amelioration (homoeopathic aggravation):→ Continue placebo. b) (ii) Aggravation of same symptoms without any relief: If intensity is mild → wait for few hours’ and if no improvement follows or worsening occurs, change of medicine is to be considered. If intensity is severe →To be withdrawn from the study and to be referred for appropriate medical care. Appearance of new symptoms a) If new symptoms are mild and do not cause much concern to the patient → placebo will be continued. b) If no improvement follows or worsening occurs → change of medicine; another indicated medicine from amongst Trial Medicines in 6 potency on the same guidelines as for the first prescription. c) If these new symptoms are severe and cause considerable discomfort to patient → change of medicine; another indicated medicine from amongst Trial Medicines in 6 potency on the same guidelines as for the first prescription. d) If the medicine indicated for change of prescription at any stage does not lies in the trial group of medicines, the case will excluded from study. 31 Chronic bronchitis protocol C. In case of no change after first or subsequent prescriptions: a) In case there is no perceptible change (either worse or better i.e. change in FDI) on next day or after few hours of administration of medicine →one dose of the same medicine in higher potency is to be repeated followed by placebo. b) In case there is no perceptible improvement after adequate repetition of medicine,[the investigator must look for any obstacle(s) to cure and steps may be taken to remove them. A record of such advice followed by the patient is to be kept in the case follow up. In case no such obstacle(s) are found, change of medicine is to be considered on the same line as mentioned in the footnote. Efforts would be made to ensure compliance of Instructions and adherence to the prescribed therapeutic schedule. In case of deviation, valid justification should be recorded. Foot note ; If aggravation/ no change in 1 day or early, depending on intensity , another medicine on the basis of modified picture of the disease is to be considered from 13 trial medicine. In case aggravation continues or no improvement comes up even after a maximum of three indicated medicines have been tried and no improvement occurs, the case is to be closed from study and declared as clinical failure. Such patients will be referred and will be treated according to the practice of the hospital/institute. Treatment of chronic disease after the acute exacerbation/acute disease subsides is to be made depending on the state of signs/ symptoms of the chronic disease i.e. the indicated medicine in suitable potency will be given only on the appearance of the chronic state and placebo to be continued till such time that there is amelioration of the chronic disease. Case will be followed up as per approach towards chronic case. 6.2.3. 6.2.4 Source of Medicines for Trial Homoeopathic medicines for the trial would be procured from the SBL Private Ltd. Sahibabad, Ghaziabad, Uttar Pradesh. Change of therapy The change of therapy or the second prescription shall be made in accordance with the guidelines mentioned for the second prescription above(4.5.2.2) 6.2.5 General supportive care Intelligent management must be based on as complete knowledge as possible of the degree of obstruction, the extent of disability, and the relative reversibility of the patient’s illness. After the initial assessment, the physician has some idea of the relative emphasis to be placed on patient education, rehabilitative and preventive measures, and direct therapeutic interventions in management of the patient and the illness. Smoking Cigarette smoking is the most commonly identified correlate with both chronic bronchitis during life and extent of emphysema at postmortem. Passive exposure to tobacco smoke correlates with respiratory symptoms such as cough, wheeze, and sputum production. The physician should always ask the patient about smoking, urge the patient to stop smoking, help the patient set a date to stop, and provide close follow up support for the patient’s efforts. Environment (Air-pollution) & Occupation The incidence and mortality rates of both chronic bronchitis and emphysema may be higher in heavily industrialized urban areas. 32 Chronic bronchitis protocol Exacerbations of bronchitis are clearly related to periods of heavy pollution with sulfur dioxide (SO2) and particulate matter. Chronic bronchitis is more prevalent in workers who engage in occupations exposing them to either inorganic or organic dusts or to noxious gases. Epidemiological surveys have succeeded in demonstrating an accelerated decline in lung function in many such workers --- e.g., workers in plastic plants exposed to toluene diisocyanate, and carding room workers in cotton mills --- suggesting that their occupational exposure contributes to their future disability. In patients in whom occupational or environmental exposures are thought to play a significant role, change of occupation or relocation of dwelling is advisable. A simple environmental change is that of eliminating aerosol sprays such as deodorants, hair sprays, and insecticides from the household. Hair sprays have been shown to produce acute airways responses even in normal subjects. Exercise Exercise programmes although not accompanied by measurable improvement in lung function, result in increased exercise tolerance and an improved sense of well-being. The improvement is usually task-specific, so most physicians advise walking in preference to the use of special apparatus, such as stationary bicycles. Nutrition If malnutrition (body weight less than 85 percent of ideal) is present, oral dietary supplements can result in improved muscle strength, less fatigability, and lessening of breathlessness. Respiratory infections Morbidity, mortality and frequency of acute respiratory illnesses are higher in patients with chronic bronchitis. Many attempts have been made to relate these illnesses to infection with viruses, myoplasmas, and bacteria. However, only the rhinovirus are found just as often between as during exacerbations. Infections cannot be totally avoided, and the patient should be made aware that increasing purulence, viscosity, or volume of secretions signals the onset of an infection, which should be treated early. Microscopic examination and culture of sputum are indicated if there are chills, fever or chest pain. Familial factors Familial aggregation of chronic bronchitis has been well documented. Children of smoking parents may experience more frequent and severe respiratory illnesses and have a higher prevalence of chronic respiratory symptoms. In addition, nonsmokers who remain in the presence of cigarette smokers (passive smokers) have increased blood levels of carbon monoxide, which indicate that they are significantly exposed to smoke. Another well-documented form of indoor air pollution relates to the use of natural gas for cooking. The role of such pollution, however, remains controversial. Thus a part of familial aggregation may be related to home air pollution. 33 Chronic bronchitis protocol 6.2.6- Plan of treatment- 1st phase treatment – “Watchful waiting”. The placebo along with the conservative treatment to be given till such time that there is improvement in the cough and expectoration. The observation is being done preferably at week’s interval or two week’s interval as required. In case of no improvement, or aggravation the 2nd phase treatment should start. The patient should not be prescribed any medicine till improvement last. 2nd phase Treatment – The indicated medicine along with the general management, to be followed up at a periodic check-up to assess the progress in the case. 7. PROCEDURES AND METHODS 7.1. Enrollment The enrollment procedure after presentation to a specific site is as follows: Four stages for Participant selection Stage 1: Preliminary verbal screening by the OPD doctor for presence of inclusion criteria (FORM A) Patients will be recruited from those coming to out patients’ department in the institutes where the study has been assigned. While each site will evolve its own advocacy procedures for attracting research subjects (advertisements, media, camps, handouts, etc.), they will all follow the standard recruitment procedure. The procedure involves a two stage screening prior to initiation of the consent procedure. The first screening is a verbal screening by the attending physician in the OPD. 34 Chronic bronchitis protocol The OPD doctor will verbally screen the patients presenting with symptoms related to respiratory system between 20-50 years of age by asking the following questions: 1. How old are you? 2. Have you been suffering from productive cough for more than three months? 3. Is there copious expectoration? Details will be kept on the number of patients screened by the OPD doctors. It is expected that the site investigators will ask the OPD doctor to screen as many patients as possible. Subjects who are of relevant age and have both, the productive cough for more than three months and the copious expectoration, will be sent to the investigating officer for detailed and recorded screening. Stage 2: Detailed screening by the investigating officer for presence of inclusion criteria and absence of all exclusion criteria. The second screening is a standardized-recorded screening by the project medical officer/investigating officer ‘FORM’ A The investigating officer will examine the patient for the presence of inclusion criteria and exclusion criteria. Those who are potentially eligible for the study (inclusion criteria present and all exclusion criteria absent) will then be subjected to a Baseline assessment by the investigating officer to re-confirm presence of inclusion criteria and absence of all exclusion criteria. Details will be kept on the number of patients screened by the investigator. For a site to stay in the study a minimum of 8 subjects must be enrolled in any month period and follow-up must be more than 95%. In addition, the site must follow the clinical parts of the protocol stringently. To complete the study within the stipulated time frame, each site is required to make all efforts to enroll at least 8 cases per month into the study. This would give a sample size of about 200. Care must be taken to recruit cases in all twelve months of a year to represent all seasons. Stage 3: Informed written consent of potentially eligible subjects The purpose of the study will be explained to patients and oral informed consent to participate obtained. The patients eligible to enter the study will be fully informed about the study. The content of the explanation provided to the patients is described in the attached consent form ( Form B1).The site investigator from all the institutions involved in the study will obtain the freely given, written consent of the patients to participate in the study. The written consent form is attached (Form B2). If the patient is not literate, a thumbprint may be substituted for signature, duly witnessed by somebody in addition to the person requesting consent. Stage Baseline assessment by the Programme officer shall include a detailed Case 35 Chronic bronchitis protocol 4: record and to re-confirming the presence of inclusion criteria and absence of all exclusion criteria after carrying out prescribed investigations. The baseline assessment, using Form C2, will be performed immediately after presentation to the site within 3 days after presentation to the site, FORM C1 includes: i) re-evaluation to ensure that no signs of severe chronic bronchitis or very severe disease are present and ii) a detailed case history for deciding a patient-specific remedy out of the disease specific medicines indicated in the case. Data collected at baseline include: 1. Name, age, address, detailed description of location and other contact information. 2. History of present illness (duration of symptoms, etc.) 3. Medical history to exclude presence of known or suspected i. emphysema, cor pulmonale, bronchial asthma, Bronchiectasis, Active pulmonary tuberculosis (open), Cystic fibrosis, Bronchopulmonary mycosis, Central airflow obstruction, acute bronchitis, pneumonia, pulmonary thrombo-embolism, left ventricular failure, pulmonary hypertension, chronic respiratory failure, spontaneous pneumothorax, Bronchogenic carcinoma. ii. Chronic bronchitis, NOS(J42) and obstructive(J44) as per ICD 10 iii. Subjects suffering from Persons requiring oxygen therapy and hospitalization; iv. Cough due to some other underlying disease. 4. Subjects currently on any other treatment (Homoeopathy or other systems) 5. Subjects who have discontinued treatment less than two weeks before, 6. Past history 7. Family history 8. Personal history 9. General and systemic examination 10. Investigations 11. Diagnosis 12. Rubric selection 13. Repertorisation 14. Selection of medicine for the Trial. 15. General management. The history should include quantification of the degree of cough, expectoration and exertional dyspnoea during activities of daily living and 36 Chronic bronchitis protocol typical activities for the patient. The physical examination should incorporate an assessment of the degree of distress of the patient. Patients who are no longer eligible for the study at the completion of baseline evaluation (e.g. because signs of severe chronic bronchitis or very severe disease have appeared) will be discontinued from the study and receive usual care as clinically indicated. All the data will be recorded. The study personnel will explain and demonstrate to the patient how to take the medicine at home at recruitment and at all subsequent follow-up visits. Enrolled into study—Yes/No Enrollment of consenter and registration. 37 Chronic bronchitis protocol 7.2 SELECT THE RUBRICS TO BE TAKEN FOR REPERTORISATION: Tick the rubric(s) found in the case No. Chest; inflammation; Bronchial tubes 1 Cough; chronic 2 Expectoration; copious; chronically 3 Cough, winter 4 Expectoration; constant, almost day and evening 5 Expectoration; copious; paroxysmal cough, after 6 Expectoration; frequent 7 Respiration; difficult; cough; with 8 Expectoration; mucous 9 Expectoration; mucous; translucent 10 Expectoration; frothy, 11 Expectoration; easy 12 Expectoration; transparent 13 Expectoration, white 14 Expectoration; purulent 15 Expectoration; difficult 16 Expectoration; yellow 17 Expectoration; thick 18 Expectoration; lumpy 19 Expectoration; balls, in shape of 20 Respiration; difficult; exertion, after 21 38 Chronic bronchitis protocol 2 1 1 1 0 0 0 0 0 1 2 0 2 0 02 3 3 3 3 3 3 3 3 3 2 0 2 0 2 03 0 0 1 0 2 1 0 0 0 0 2 1 1 0 04 0 0 0 0 0 0 0 0 0 0 0 0 0 0 05 0 0 0 1 0 0 0 0 0 0 0 0 0 0 06 0 1 0 1 2 0 0 0 0 0 0 0 0 0 07 3 2 0 1 3 3 1 2 2 0 1 1 3 2 08 3 3 3 1 3 3 3 3 2 2 3 3 2 3 09 0 1 0 0 0 3 0 0 0 0 0 0 0 0 10 2 1 0 1 0 3 1 0 0 0 0 1 1 1 11 0 1 1 1 3 0 0 0 1 1 0 0 1 1 12 3 2 0 1 2 2 0 2 0 0 0 1 1 0 13 3 1 1 2 2 2 2 2 2 0 0 1 1 0 14 3 3 1 1 2 2 3 0 1 0 2 1 2 1 15 2 0 2 1 3 2 2 3 0 1 2 1 1 2 16 3 3 0 2 3 2 3 1 2 1 2 1 0 0 17 3 2 2 3 3 2 2 0 3 2 1 1 0 0 18 1 3 2 1 2 2 2 2 1 1 1 1 1 0 19 1 3 0 1 2 2 0 0 1 1 0 1 0 1 20 0 3 0 1 3 2 1 0 0 0 0 0 0 0 21 2 2 0 2 2 3 3 0 2 0 2 0 0 3 Sil. Phos Lyc. Puls. Calc. Sulph. Hep. Ip. Bry Ant-t Carb-v. Spong. Stann. Total 01 Ars. 7.3 Highlight the row(s) below corresponding to the rubric no(s). ticked above: 39 Chronic bronchitis protocol 7.4 High scoring medicines: Medicine: Value: 7.5 Basis of prescription Prescription: ____________ Potency: 30. single Highlight the disease symptom(s) of the case No. State the characteristic symptoms Chest; inflammation; Bronchial tubes 1 Cough; chronic 2 Expectoration; copious; chronically 3 Cough, winter 4 Expectoration; constant, almost day and evening 5 Expectoration; copious; paroxysmal cough, after 6 Expectoration; frequent 7 Respiration; difficult; cough; with 8 Expectoration; mucous 9 Expectoration; mucous; translucent 10 Expectoration; frothy 11 Expectoration; easy 12 Expectoration; transparent 13 Expectoration, white 14 Expectoration; purulent 15 Expectoration; difficult 16 Expectoration; yellow 17 Expectoration; thick 18 Dose: 40 Chronic bronchitis protocol Expectoration; lumpy 19 Expectoration; balls, in shape of 20 Respiration; difficult; exertion, after 21 41 Chronic bronchitis protocol 7.6 Assessment 7.6.1 (periodical – two-weekly) The “zero” will be the time of enrollment. The study personnel will call the patient every two weeks or earlier, if need be, for the follow-up visit and will examine the patient. The investigator will review the key variables. Those patients who smoke will be advised to quit smoking. All the patients will be taught to recognize the signs of worsening illness according to those outlined in Baseline assessment form. They will be advised to report to the Institute if any of the signs develop at any time before the scheduled visit. The following observation will be made and recorded in case report forms: 1. Presence or absence of productive cough. 2. Change in expectoration. 3. Status of exertional dyspnoea 4. Presence or absence of added sounds in chest. 5. Presence or absence of fever. 6. Any ill contacts; any associated symptoms such as nausea, vomiting, diarrhea, myalgias, and chills. 7. Signs of severe chronic bronchitis. 8. Signs of very severe disease. 9. Number of doses of medicines taken. 10. If the patient does not report on a date (fixed) contact shall be made in any way. The investigator should attempt to establish the severity of exacerbation as well as the severity of pre-existing disease condition. The more severe, either of these two components, the more likely, that the patient will require hospital admission. 7.6.2 Outcome assessment On each follow-up visit an assessment of clinical success or failure shall be made depending upon an overall response to treatment and the same shall be recorded in a master assessment chart. 7.6.3 Final Assessment 42 Chronic bronchitis protocol Assessment of cure will be done either after all the potencies (30, 200 and 1M) of the trial drug have been used or after a lapse of a term of 6 months from enrollment of the patient whichever be earlier. Patients who are clinically cured will be discontinued from therapy and put on periodic observation for a symptom-free period up to two years. Those who are not improved will be given a changed therapy after a wash-out period of two weeks, following the same guidelines as for the selection of the first prescription and this case shall be taken as a new drug trial case in the study. Degree of improvement1. Marked ( more than 75% improvement in Symptom score from Base line score) 2. Moderate ( 50% to less than 75% improvement in Symptom score from Base line score) 3. Mild ( 25% to less than 50% improvement in Symptom score from Base line score) 4. Not Significant ( less than 25% improvement in Symptom score from Base line score) II Worsened ( Increase of Symptom score from Baseline) III Static ( No change of Symptom score from Baseline) 7.7. Treatment schedule (time-line) - -(clinical study on chronic Bronchitis) Sl. Time No. 1 Day 1 Event Screening Form to be filled FORM A 2 Day 2-5 Baseline assessment and inclusion into study, consent, case recording and repertorisation 3 Day 6-8 Homoeopathic therapy initiated FORMS B1, B2, C1, C2 , Repertorisation Sheet Ref. 4.5.2 1 month to 3rd month 5 On completion of 3 months 6 On completion of 1 year 7 1 year to 2 year 8 On completion of 2 9 2 year to 3 year 10 On completion of 3 years Monthly follow-up with photographs FORM D Detailed assessment in comparison with baseline assessment and photographs FORM E Repeat assessment, plus photographs and continuation of therapy, if required FORM H Monthly follow-up as required and continuation of therapy, if required Repeat assessment, plus photographs FORMS D, E1, F1 & G1 FORM H1 Monthly follow-up as required and continuation of therapy, if required To prepare the Summary report of each case studied, so far, under this clinical study FORMS D, E2, F2 & G2 FORM H2 11 After completion of 3 years+ Concluding Report FORM I 4 43 Chronic bronchitis protocol 2 months 8 CRITERIA FOR WITHDRAWAL OF PATIENTS 8.1 when and how to withdraw the subject It is the responsibility of the site investigator to maintain the patient in the study, provided it is safe to do so. A patient may be discontinued from the study for any of the following reasons, that must be documented on the appropriate case report form: 8.1.1. Clinical failure after complete treatment 8.1.1.1 No change in Symptomatology of the subject 8.1.1.2 Aggravation of complaints of the patient 8.1.2 occurrence of a serious adverse event 8.1.2.1 No improvement in symptom score from baseline assessment score 8.1.2.2 Serious Intercurrent illness 8.1.2.3 No adverse events are expected during homoeopathic therapy. But adverse events may occur as the natural course of the disease. 8.1.3. Patient withdraws consent 8.1.4. Protocol is not followed 8.2 Data collection and Clinical care of withdrawal patients 8.2.1 Such patients will receive medical treatment as directed by their physician. 8.2.2 Procedures at discontinuation of enrollment The site investigator is responsible for completion of all appropriate case report forms up to the time that the patient is discontinued from the study. 44 Chronic bronchitis protocol 9 RECORD HANDLING 9.1 confidentiality all the evaluation forms, reports and other records will be kept in locked file cabinet. The patient shall be issued an identity card as follows: Patient identity card for follow up Patient initials ---research case no--Project.-----------------/yr date of enrollment----Date of initiation of treatment---------completion of treatment---- date of 12th month 11th month 10th month 9th month 8th month 7th month 6th month 5th month 4th month 3rd month 2nd month remar ks date 1st month month Followup visits----. 9.2 RECORD KEEPING There are 10 study forms that will be completed by all the sites for each subject recruited. There are 2 Consent forms for obtaining the informed written consent of the enrolled case. There are 3 reporting proformas, which are to be sent to HQ, at specified time. 9.3 Dissemination, notifications & reporting – 9.3.1 All data derived from the multicentric study will be the property of the Council. 9.3.2 The principle papers on the primary and secondary out comes emerging from the multicentric study will be published under joint authorship (task force study). The names of the scientists who have participated in the proposal development and data analysis will be listed at the end of the paper in alphabetical order and their specific contribution to the study will be mentioned. 9.3.2 Sites participating in the multi centric study will then be listed in alphabetical order. Authorship issue for site investigators will rest with the Director of the Council. Each site team will be encouraged to produce scientific manuscripts and technical 45 Chronic bronchitis protocol reports based on their site-specific data. Scientists will be encouraged to present the findings at scientific conference and meetings with the prior approval of the Director, CCRH. 9.4 Study management at site: Each site will be responsible for setting up an information system to keep track of all patients screened and enrolled and a filling system to keep all study records – case history records, study protocol and or related documentation and drug distribution records. The site investigator is responsible for the completeness and accuracy of the study materials 9.5 Case History records: These include the study case report forms (CRFs) that will contain information that documents the subject’s ability to participate in the study (including a copy of a signed consent form) and information from tests and examinations. Whenever possible copies of supporting documentation of the information contained in the study case report forms should be kept with each patient’s case history records. All information in the case history records should be attributable to a specific individual. Each subject’s case history record will be evaluated to verify the validity and completeness of the data on the CRF when a study monitor visits the study site. Each CRF should be complete with follow up sheets and are to be maintained properly. All corrections to the CRFs must be made without obscuring the original entry. The revised entry should be inserted and the person making the correction should sign and date the correction. Only authorized study personnel may complete or correct case report forms 9.6 Records retention: Retention of accurate and complete records is essential to establish the validity and completeness of the study. All records must be retained for 5 years after the data set is frozen 10. MONITORING AND INSPECTION 10.1 Project Monitoring and reviews : 1. Site visits: Site visits will be made by the monitoring officer at CCRH Hqrs. between 3-6 months after commencement of studies. 2. Presentation of interim data by the site investigator will be made at Hqrs. 3. Data review board will monitor the information with respect to deviations from the study protocol, in- appropriate enrollment of study subject, missed observations etc. and will suggest plan to rectify any problems at the site. 10.2 Interim assessment of the study On the basis of interim report received from the different centers involved in the clinical study, assessment will be made regarding progress of the clinical study, Interim analysis 46 Chronic bronchitis protocol will be placed before the data review board for suggestions in improvement or modifications, if required in the protocol. DRB will also assess for compliance of protocol by the study site. Non compliance may result into closure of study at particular site. 10.3 Quality control: Once the project has been cleared by the Scientific Advisory Committee and Ethical Committee, a centralized workshop will be organized for research officers (to be involved in specific study) to ensure standardization and quality control. An external reviewer will visit all the sites after the initiation of the study for quality assurance. A random subset of records from each site will be evaluated for quality control. Investigators will be asked to bring all medical records ( and results of laboratory tests etc.) for selected subjects to data analysis workshop. Information in the medical records will be compared with the data on the case report form to assess completeness and accuracy of reported data. 11 DATA ANALYSIS AND MANAGEMENT: 11.1 Reporting Guidelines 1. All centres will send monthly report as per reporting proforma 1 on case recruitment to headquarters either by fax or e-mail on 1st to 7th of each month. 2. An interim assessment report as per reporting proforma 1I of all the cases enrolled is to be submitted on completion of 3rd month of the study of the study. 3. An interim assessment report as per reporting proforma 1II of all the cases enrolled is to be submitted on completion of 6th month, 9th month, 1st yr, 2nd yr,3rd yr of the study of the study. 3. Data review board will assess the research data as reported in 6 months assessment form as well as first and second interim report. 4. Final assessment report on completion of the study (after 3 years) is to be submitted to hqrs as per reporting proforma IV. 11.2 Data analysis plan : Co-ordinating cell at CCRH hqrs. will finally compile and analyze data received from all the centres in consultation with Data Review Board. 11.3 Institutional Data Review Board Institutional Data Review Board (IDRB) shall make Interim review of the data of the study every six months. 12 TRAINING A training module will be prepared detailing out various modes of training to be imparted to the concerned staff at each of the centers of trial. 47 Chronic bronchitis protocol 13 ETHICAL REVIEW Although homoeopathic medicines, proposed to be used during the study, are homoeopathic pharmacopoeal preparations (no new drug is proposed to be tried)Necessary Clearance of the Ethical Committee has been obtained before under taking the study 14 LIMITATIONS OF STUDY: 1. Non achievement of sample size at a particular site/centre – i. In case of non achievement of sample size in the study period, there will be option for extension of the study for a further limited period after due approval of Scientific Advisory Committee of the Council. ii. If a particular site/centre fails to achieve the sample size in first 6 months, or not complying to the protocol, the study will be discontinued and there will be an option for inclusion of one more centre after due approval of Scientific Advisory Committee. 2. Since only a group of medicines have been selected for trial to minimize variables, it may be possible that in some cases, medicines out of these trial medicines may be indicated as per symptom similarity. Those cases are to be treated according to general treatment guidelines of Homoeopathy and are not to be included in the study. 15. Time line 1. Draft protocol, submit to EC and IDRB and Constitution and 1st meeting of the Data Monitoring committee oct 2005 2. Pre-trial preparations: Organise purchase of drugs, equipment, furniture, etc., printing of programmes for data entry and management November 2005 3. Quality assurance workshops (For standardized training of appointed investigators at all centres in outcomes assessment, data collection, reporting, etc.) November 2005 4. Recruitment in main study november 2005 onwards till the specified sample size is achieved, or two years, 48 Chronic bronchitis protocol whichever be earlier. 6. Quality assurance site visits: Quarterly 7. Interim analysis April 2006, -07, -08 and 2009 8. Subsequent meetings of *Data Monitoring Committee October 2006, 2007, 2008 and 2009 9. Data compilation and analysis December 2009 *The Data Monitoring Committee can meet at any time on the call of the Chairperson 16. CASE DEFINITIONS 16.1 Chronic bronchitis A condition associated with excessive tracheobronchial mucus production sufficient to cause cough with expectoration for at least 3 months of the year for more than 2 consecutive years. The patient with chronic bronchitis with obstruction has a long history of cough and sputum production with a later onset of wheezing, whereas the asthma patient with chronic obstruction gives a long history of wheezing with later onset of chronic productive cough. The patient with predominant bronchitis usually has an impressive history of cough and sputum production for many years with an immodest history of cigarette smoking. Initially the cough is present only in winter months, and the patient is apt to seek medical attention, if at all, only during the more severe of the frequent mucopurulent relapses. Over the years the cough progresses from hibernal to perennial and mucopurulent relapses increase in frequency, duration and severity. After beginning to experience exertional dyspnoea, the patient often seeks medical help and will be found to have a severe degree of obstruction. The patient with predominant bronchitis is often overweight and cyanotic. There is apparently no apparent distress at rest, the respiratory rate is normal or only slightly increased, and there is no apparent usage of accessory muscles. Chest percussion note is normally resonant, and by auscultation one can usually hear coarse ronchi and wheezes that change in location and intensity after a deep and productive cough. 16.2Simple Chronic bronchitis Chronic bronchitis characterized by mucoid sputum production 16.3Chronic mucopurulent bronchitis Chronic bronchitis with persistent or recurrent purulence of sputum in the absence of localized suppurative diseases such as bronchiectasis. 49 Chronic bronchitis protocol 16.4 Chronic obstructive pulmonary disease (COPD) Defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD), as a disease state, characterized by airflow limitation that is not fully reversible. COPD includes Emphysema, an anatomically defined condition characterized by destruction and enlargement of the lung alveoli; Chronic bronchitis, a clinically defined condition with chronic cough and phlegm; and Small airways disease, a condition in which small bronchioles are narrowed. 50 Chronic bronchitis protocol COPD is present only if chronic airflow obstruction occurs; chronic bronchitis without chronic airflow obstruction is not included within COPD. 16.5. Coarse ronchi and wheezes Added sounds are abnormal sounds that arise in the lung itself or in the pleura. The added sounds most commonly arising in the lung are best referred to as wheezes and crackles. Older terms such as rales to describe coarse crackles, crepitations to describe fine crackles,and rhonchi to describe wheezes are poorly defined, have led to confusion, and are best avoided. Wheezes are musical sounds associated with airway narrowing. Widespread polyphonic wheezes, particularly heard in expiration, are the commonest and are characteristic of diffuse airflow obstruction, especially in asthma and chronic obstructive pulmonary disease. These wheezes are probably related to dynamic compression of the bronchi, which is accentuated in expiration when airway narrowing is present. A fixed monophonic wheeze can be generated by localized narrowing of a single bronchus, as may occur in the presence of a tumour or foreign body. It may be inspiratory or expiratory or both and may change its intensity in different positions. Crackles are short, explosive sounds often described as bubbling or clicking noises. When the large airways are full of sputum, a coarse rattling sound may be heard even without the stethoscope. However, crackles are not usually produced by moistness in the lungs. It is more likely that they are produced by sudden changes in gas pressure related to the sudden opening of previously closed small airways. Crackles at the beginning of inspiration are common in patients with chronic obstructive pulmonary disease. Localized loud and coarse crackles may indicate an area of bronchiectasis. Crackles are also heard in pulmonary oedema. In diffuse interstitial fibrosis, crackles are characteristically fine in character and late inspiratory in timing. (7) 16.6. Exertional dyspnoea The development of exertional dyspnoea, often described as increased effort to breathe, heaviness, air hunger, or gasping, can be insidious. It is best elicited by careful history focused on typical physical activities and how the patient’s ability to perform them has changed. Activities involving significant arm work, particularly at or above shoulder level, are particularly difficult for patients with COPD. Conversely, activities that allow the patient to brace the arms and use accessory muscles of respiration are better tolerated. Examples of such activities include pushing a shopping cart, walking on a treadmill, or pushing a wheelchair. As COPD advances, the principal feature is worsening dyspnoea on exertion with increasing intrusion on the ability to perform vocational or avocational activities. In the most advanced stages, patients are breathless doing simple activities of daily living. 16.7 The physical examination It should incorporate an assessment of the degree of distress of the patient. Specific attention should be focused on tachycardia, tachypnea, use of accessory muscles, signs of perioral or peripheral cyanosis, the ability to speak in complete sentences and the patient’s mental status. The chest examination should establish the presence or absence of focal findings, degree of air movement, presence or absence of wheezing ,asymmetry in the chest examination (suggesting large airway obstruction or pneumothorax mimicking an exacerbation) and the presence or absence of paradoxical motion of abdominal wall. 51 Chronic bronchitis protocol 52 Chronic bronchitis protocol 16.8 Alterations in Ventilatory Function(2) TLC RV VC FEV1/FVC MIP MEP N to a N N Pulmonary parenchymal N to N N Extraparenchymal - inspiratory N to N /Nb N Extraparenchymal – inspiratory + expiratory Variable /Nb /Nb Obstructive Restrictive a Mild obstructive (small airways) disease may have decreased FEF25-75% with normal (N) FEV1/FVC b Reduced if due to respiratory muscle weakness; normal if due to chest wall stiffness.obstructive (small airways) disease may have decreased FEF25-75% with normal (N) FEV1/FVC TLC = Total Lung Capacity RV = Residual Volume VC = Vital Capacity FEV = Forced Expiratory Volume FVC = Forced Vital Capacity MIP = Maximum Inspiratory Pressure MEP = Maximum Expiratory Pressure FEF = Forced Expiratory Flow 53 Chronic bronchitis protocol 17 BIBLIOGRAPHY 1. Eugene Braunwald, et al. Harrison’s Principals of Internal Medicine, Volume II, McGrawHill, Medical Publishing Division, 15th Edition 2001; 258:1451-1459.. 2. Kasper Dennis L., et al. Harrison’s Principals of Internal Medicine, Volume II, McGrawHill, Medical Publishing Division, 16th Edition 2005; 242:1547-1554. 3. Tierney, Lawrence M., et al. CURRENT Medical Diagnosis & Treatment, Lange Medical Books/McGraw Hill, Medical Publishing Division, 44th Edition 2005; 9: 235-240. 4. W.H.O., ICD-10, International Statistical Classification of Diseases and Related Health Problems, Volume 1, World Health Organization, Geneva, Tenth Revision 1992; J40J47:533-537. 5. Haslett, Christopher, et al. Davidson’s Principles and Practice of MEDICINE, Churchill Livingstone, 19th Edition 2002; 13:508-512, 516. 6. Swash Michael. HUTCHISON’S CLINICAL METHODS, W.B. SAUNDERS, 21st Edition 2002; 5:67. 7. Zendvoort, Roger Van. Complete Repertory, Mac Repertory for Windows, Kent Homoepathic Associates, USA. 8. Dubey, S.K. Textbook of Materia Medica. Calcutta, Hahnemann Publishing house 9. Hahnemann, Samuel. Organon of Medicine. 6th edition. New Delhi, B. Jain Publishers. 54 Chronic bronchitis protocol 18 ATTACHMENTS 18.1 FORMS (relating to cases registered for clinical study) Sl.no. FORM Name Period Page no. 1 FORM A Detailed screening form At the time of registration in OPD 66 To be filled for each case reported in OPD for the treatment of tropical eosinophilia 2 Form B1 Patient’s information sheet 67 once 3 FormB2 Written consent form In case of absence of exclusion criteria 68 To be filled once in each case, registered for assigned clinical study 4 FormC1 Case taking proforma To be taken for eligible subjects 69 To be filled once in each case, registered for assigned clinical study 5 FormC2 Baseline assessment form -do- 77 To be filled once in each case, registered for assigned clinical study 6 FormD Follow up monthly (assessment)every visit 80 Minimum12(mainly depends on no. of visits of patient during the course of study) 7 FormEG Assessment – 3rd, 6th, 9th months 3rd month/6th 82 month/9th month/15th month/18th month27th month/21st month/30th month/33rd month Maximum 01(mainly depends on no. of visits of patient during the course of study) 8 FormH Assessment – on completion of 1 year 1st year/2nd year/3rd year Maximum 01(mainly depends on no. of visits of patient during the course of study) 89 55 Chronic bronchitis protocol 18.2 Study periodical reporting proformae(to be submitted during the course of study) Sl.no. Study proforma Name Number Page no. 1 study reporting proforma I Monthly reporting proforma 12x3 years=36 91 Contains information related to the month reported for 2 study reporting proforma II Interim report(after 3 month) 1x3years=3 92 Contains information related to three months(April- June) of the year reported for 3 study reporting proforma III Interim report(after 6th month/9th month/1st yr/2nd yr/3rd yr 1x3years=3 in each specified period 96 Contains information related to 6/9/12 months(April to Sept:6 months/April to December:9 months/April to March of the subsequent year:1 year) of the period reported for 4 study reporting proforma IV Consolidated report 1 100 Contains detailed information related to all events within three years(April 2006 –March2009) 18.3 Others 18.3.1 18.3.2 List of Monitoring committee o Dr. Vikram Singh, Co chief coordinator, o Dr. Hari Singh,Co chief coordinator, o Dr. Jaya Gupta,coordinator, o Programme officer at the unit or Incharge of the unit. List of institutional data review board 56 Chronic bronchitis protocol FORMS: FORM A Detailed Screening Form Serial number __________ Site Code ______________________ Date _________________ 1. Age _____________ 2. Sex: Male/Female 3. Is age >20 and <50 years Yes No 4. Reason for OPD attendance: 1. Productive Cough for more than 3 months Yes No 2. Copious expectoration Yes No 5. Did he/she suffer from similar cough the previous year Yes No 6. If ‘yes’ to Sr. Nos. 3, 4 and 5, go through the list below: Acute Bronchitis Yes No Bronchial asthma Yes No Bronchiectasis Yes No Cystic fibrosis Yes No Pneumonia Yes No Broncho-pulmonary mycosis Yes No Central Airflow Obstruction Yes No Cor pulmonale Yes No Emphysema Yes No Pulmonary Tuberculosis Yes No Need of Oxygen therapy or Hospitalisation Yes No Pulmonary Thrombo-embolism Yes No 57 Chronic bronchitis protocol Pulmonary Hypertension Yes No Bronchogenic Carcinoma Yes No Chronic Respiratory Failure Yes No Left Ventricular Failure Yes No Spontaneous Pneumothorax Yes No Systemic Diseases Yes No Cough due to some other underlying disease Yes No If ‘Yes’ to any one of the above in Q 6, exclude the patient from the study. IF INCLUDED, PROCEED TO FORM B (BASELINE ASSESSMENT) Signature Investigator Signature incharge of the institute/unit 58 Chronic bronchitis protocol FORM B1 Patient Information Sheet Unique identifier __ / __ __ __ / __ __ __ __ To evolve a group of most efficacious homoeopathic medicines in ‘Simple and Mucopurulent Chronic bronchitis’ with regard to improvement in the symptom complex of ‘Simple and Mucopurulent Chronic bronchitis’ : A multicentric open clinical trial Purpose of the study Patients, suffering from perennial chronic cough and copious phlegm which are the symptoms of chronic bronchitis, need regular and longer treatment. Generally such patients seek allopathic treatment. Homoeopathic medicines have also been found to be effective in relieving the distress to a great extent. So far there are no clear cut guidelines for treating chronic bronchitis using homoeopathic medicines. In this study, we propose to evaluate the efficacy of homoeopathic medicines in chronic bronchitis. Study procedures You have now been screened and it is likely that you are suffering from chronic bronchitis, which is not severe and can safely be treated at home. We invite you to enroll yourself in this study. If you are willing to be enrolled in the study, you will be required to undergo certain investigations at the time of enrolment, free of cost such as Pulmonary Function Test for measuring the capacity and functioning of your lungs, blood examination, sputum examination and X-ray chest.You will be examined for the sevierity of the your sufferings.There will be no adverse affect of any kind by any of these investigations, examinations and treatment. You will be given homoeopathic treatment for your complaints by which you will be relieved of your ailments. The benefits to you will be that you will be provided close medical follow up free of cost by a separate physician and this may also be benefited to any other patient suffering from similar complaints. You will not know the contents of the medicines prescribed to you during the trial period but this information will be available to your doctor. Medicine will be supplied in the form of sugar globules, which will have to be given in doses as your doctor may deem fit for you. You will be required to be present for follow up every two weeks or earlier if need be for assessment, after commencing the treatment Risks from the study No serious risks are anticipated in this study. We are assuming that you will recover after homoeopathic treatment given in this trial. However, it is possible that you may not recover completely. You will be closely followed up and additional treatment administered, if necessary. The homoeopathic treatment is one of the commonly used treatments for chronic bronchitis. It has a good safety profile. Benefits from the study The results of this study will benefit society by providing information that may justify treatment of patients suffering from chronic bronchitis that will result in considerable cost savings and may prevent the patient from developing complications of the disease The benefits to you will be that you will be provided free consultation and close medical follow up. All medications and investigations for this study will also be provided free of cost. Complications We do not anticipate any serious complications during the study. However, complications may occasionally arise during the course of the study, due to the disease process. Treatment of such complications will be carried out by the doctors at no cost to you. No financial compensation will be provided for such complications. 59 Chronic bronchitis protocol Compensation There will be no other financial compensation for participation in the study. Confidentiality All information collected in this study will be kept strictly confidential except as may be required by law. You will not be identified by name if the results of the study are published. Rights of the participants Participation in the study is voluntary. Refusal to participate will not influence your care in this centre in any way. Though we would like all study participants to complete the study, you are free to withdraw from the study at any time during the course of the study. If at any time during the course of the study, you have any questions or concerns related to the study, you may contact the following doctor: Director , Central Council of Research in Homoeopathy, New Delhi 110058. Phone numbers 25505523, Fax:91-11-25506060 Email- [email protected] Alternatives to participation in the study You will be seen by one of the doctors in the clinic and provided treatment according to the regular treatment protocol of the institute. 60 Chronic bronchitis protocol Form B2 Written Informed Consent Form Unique identifier __ / __ __ __ / __ __ __ __ Consent I have had the study explained to me and have read the contents of this form/had the contents of this form read to me. I have understood the same. I have been given the opportunity to ask questions and have them answered to my satisfaction. I am willing to be enrolled in the study. Name of the subject: Unique identifier __ / __ __ __ / __ __ __ __ (Site/serial/registration numbers) Signature of patient_________________________________ Date _______________ Signature of the investigator_________________________________ Date _______________ Name of the investigator_________________________________ Signature of witness_________________________________ Date _______________ Name of witness_________________________________ 61 Chronic bronchitis protocol Form C1 Case recording proforma Registration No………………… Date….…………….. Name………………………………….. Name…………………………… Father’s/Husband’s Age………years Sex - Male/ Female Religion…………….Nationality…………… Marital status - Single/Married/Widow(er)/Divorcee Height ……’….” Weight………KG Diagnosis………………………… Occupation……………… Official Address………………………………………………….. ………………………………………………….…………………. …………………………………………………………………….. Telephone ………………………E.mail……………………….. Residential address: (A) Temporary: Address……….………………………………………………….. ………………………………………………….…………………. …………………………………………………………………….. Telephone ………………………E.mail……………………….. (B) Permanent: Address……….………………………………………………….. ………………………………………………….…………………. …………………………………………………………………….. Telephone ………………………E.mail……………………….. Attending Physician: ………………………………. ___________________________________________________________________ SUMMARY (To be filled after complete case taking) 62 Chronic bronchitis protocol PATIENT’S NARRATION (in the very expressions used by him) PHYSICIAN’S INTERROGATION [ DETAILS REGARDING SYMPTIOMS NARRATED] 63 PHYSICIAN’S OBSERVATION Chronic bronchitis protocol PATIENT’S NARRATION (in the very expressions used by him) PHYSICIAN’S INTERROGATION [ DETAILS REGARDING SYMPTIOMS NARRATED] 64 PHYSICIAN’S OBSERVATION Chronic bronchitis protocol 2. A. PRESENTING COMPLAINTS (in chronological order with duration.) Each symptom should be completed. location & extension( includes tissues, organs,systems. Extention & spread. Duration & Frequency) Sensation (includes pathology ) Modalities includes < & > concomitants B. Associated complaints(in chronological order with duration.) Each symptom should be completed. location & extension ( includes tissues, organs,systems. Extention & spread. Duration & Frequency Sensation (includes pathology ) Modalities includes < & > 65 concomitants Chronic bronchitis protocol 3. HISTORY OF PRESENT ILLNESS ( includes nature of onset, duration, progress, mode of treatment, effect of treatment, and any relation with cause*) 66 Chronic bronchitis protocol 4. LIFE SPACE INVESTIGATIONS (should take form of a biographical account) Record, if any factor, out of these has relation with present complaints or effect on mind and disposition of the patient: 4.1 Birth and early development (Mother’s condition during pregnancy; normal or abnormal birth; feeding difficulties, difficulties in habit training and delay in achieving milestones (walking, talking and sphincter control, etc.). 4.2 Behaviour during childhood (Play and favourite toys; any periods of separation from parents and the patient’s reaction to them; temper tantrums; hyperactivity; frequent fights; violence; model child. Bed-wetting or soiling; eating problems; stammering; recurrent physical complaints, e.g. abdominal pain). 4.3. Schooling (Age of starting and finishing school; type of school; academic achievements; special abilities or disabilities; relationship to peers and teachers; school refusal; school truancy; ambitions. Obtain information for both primary and secondary schooling). 4.4. Adolescence & Psychosexual history (Introduction to facts of life; early sexual experiences; parental attitude towards sex; sexual abuse in childhood. Masturbation and sexual fantasies; homosexual and heterosexual experiences apart from marriage; emotional relationship to partners; sexual difficulties; sexual deviation; current sexual activities. Attitudes to parents, authority figures and peers; reaction to growing up, puberty and bodily changes; fantasy life; attitude to sexuality including masturbation and any early homosexual and heterosexual experiences; drug taking; rebelliousness and delinquency. New interests). 4.5. Occupational history (Age of starting work; jobs held in chronological order and reasons for change; satisfaction from work; work ability and ambitions; relationship to work mates, superiors and subordinates. Leisure activities). ____________________________________________________________________________ _________________________ *- precipitating/ exciting/ never well since/ ailments from 67 Chronic bronchitis protocol 4.6. Marital history (Previous engagements and marriages; reasons for marriage; husband’s or wife’s age, occupation, health and personality; marital relationship – satisfactions, dissatisfactions, any sexual difficulties; extra-marital relationships and sexual fantasy life). 4.7. Children (Chronological list of children with ages, first names and health. Miscarriages, stillbirths or death of a child. Patient’s reactions to these events and attitude to existing children). 4.8. Present social history (housing, composition of household, financial problems, emotional atmosphere of home and its effect on patient, diet and daily routine etc.) 4.9. Alcohol and drug history (Details of smoking and drinking habits; any recent change or adverse effect on physical health or social activity, e.g. occupation, family relationships and financial situation. Use of other drugs, e.g. heroin, LSD, cocaine, amphetamines, barbiturates, cannabis, tranquillizers. How are they obtained – prescription, black market? How are they financed? 4.10 Travel history 4.11Personality before illness (Pre-morbid personality)- include relationships, leisure activities (hobbies and interests, membership of societies and clubs), predominant mood (anxious, worrying, cheerful, despondent, optimistic, pessimistic, self depreciating, over confident; stable or fluctuating; controlled or demonstrative), character (sensitive, reserved, timid, shy, suspicious, jealous, resentful, quarrelsome, irritable, impulsive, selfish, self centered, self conscious, lacking in confidence, dependent, strict, fussy, rigid, meticulous, punctual, excessively tidy), attitudes and standards (moral and religious, attitude towards health and the body), habits (food, alcohol, tobacco, drugs) 68 Chronic bronchitis protocol 4.12. Date 5. S. no. Life chart of the patient: Age Events Cause Expression Inference PAST MEDICAL HISTORY (Illnesses, operations and accidents in chronological order; treatment received – when and by whom. The patient’s reactions to them). Approx. Age/Year **Past Illness (including duration of illness) Treatment Adopted Response **- Includes diagnosed illnesses (if records available) / otherwise presenting complaints & nature of illness. 69 Chronic bronchitis protocol 6. FAMILY HISTORY (in case of adoption or fostering, details should be taken of both the real family, if possible, and the adoptive or foster family): Relation Alive (age) Dead (with age) Cause of death Father Mother Brother Sister Son Daughter Grandfather (P) Grandmother (P) Grandfather (M) Grandmother (M) Uncle (P) Aunt (P) Uncle (M) Aunt (M) Husband /Wife 7. MENSTRUAL HISTORY (if applicable): Menarche: Complaints related to Menarche, if any: 70 Illnesses suffered /suffering from Chronic bronchitis protocol L.M.P.: Regular/ Character of Flow COMPLAINTS irregular Quantity Consistency Colour Odour Acridity Before During After Cycle/ & clots & menses Duration Stains B. Changes in menstrual functions: Early years Ist 3-4 years: Marriage before: Marriage after: Pregnancy (ies) after: Recent: C. Climacteric: Age of menopause: Complaints associated with menopause: Post menopausal complaints: D. Abnormal discharges per vagina/ Leucorrhoea: Character of discharge Quantity & Colou consistenc r & y Stains Odou r Acridit y Relati on Modalities including with precipitating factors mense s Concomitants 8. OBSTETRIC HISTORY (if applicable): Data of childbirths, including miscarriages and therapeutic abortions, and complaints related with pregnancies, labor, puerperium and lactation. 7.1 Previous pregnancies including abortion: 71 Chronic bronchitis protocol G (gravida) No. Period of pregnan cy P (para) Complaint s in pregnancy / treatment adopted A (abortion) Date & nature of labor* Nature of puerperium S (still birth) L (Living) Child Birt Aliv h e or wt. dea d Causes of death *- Delivery : Home/Hospital, Normal/CS/forceps, episiotomy 7.2 H/o Any gynaecological surgery or intervention If yes, state the reason: Yes/No 7.3 Contraceptive methods used/ using: Reason of change of contraceptive methods Any complaint from use of contraceptive methods 8. PHYSICAL GENERALS (especially change during illness should be highlighted): Appetite Taste Thirst Desire / Cravings Aversion/ Repugnance Food Aggravation/ Intolerance Food Amelioration Stool 1 Physical properties 2 frequency 3 urging 4 satisfaction 5 Modifying factors 6 concomitants 7 any other 72 Lactatio n history Chronic bronchitis protocol Urine 1 Physical properties 2 Frequency (day/night) 3 urging 4 difficulty 5 control 6 pain 7 Any other Sweat 1 Physical properties 2 location 3 staining 4 in relation to weather 5 Any other Discharges 1 Abnormal secretions 2 Excretions Urethral discharge (In men) 1 Physical properties 2 Modifying factors 3 Concomitants Sleep (Pattern, position of body during sleep, sleep related problems, effect of sleep on health) Dreams[ Recurrent Persistent,Vivid ] Tendencies 1 Haemorrhagic 2 Suppurative 3 Catching cold 4 Spasms/Cramps/Sprain 5 Any other Weakness Tiredness (Is it loss of energy or boredom, or a part of general malaise?) 73 Chronic bronchitis protocol Is there unusual fatiguability? Lassitude General reaction to: Factors Aversion Desires Intolerance/ Aggravation Amelioration Sensitive to Time Thermal/ Season Air/fanning Clothing Bathing/Washing Any food items Touch/Pressure Posture Motion Noise Light Odour Any other factor(s) 9.- PSYCHIC FEATURES* with causative or modifying factors, Aberration of mind, morbid affections of the moral & intellectual. A. EMOTIONS (anxiety, anger, fears, greed, company, consolation, conversation, spoken to, suicidal tendencies, contradiction, trifles, exertion/ work, pleasure/music, magnetized etc. including History of emotional upset i.e. anger, bad news, displeasure, repressed / suppressed), disappointment, fright, grief, joy, shock,sorrow,tension,vexation,worries,etc.) 74 Chronic bronchitis protocol B. INTELLECT & MEMORY - - {includes Perception (acute/clear/confused/dull, ecstasy, clairvoyance, visions, hallucination, illusion etc.), Thinking (active/ sluggish, emotional/ logical, fancies/ daydreams, difficult, fixed/ changeable, grandiose/ unreal/ practical, reverie / systematic, delusions/imaginations, confusion, guilt complexes comprehension, etc., if any other, specify. loss-sudden, weak, acute/sharp, difficult, absent-minded, forgets recent event(s) but remembers past events, forgets names/titles/places, etc.) C WILL including desire/aversion in general(/ special senses ,strong with a drive D BEHAVIOUR OF PATIENT - Mild & Placable / Boisterous & Violent/ Firm/ Yielding/ Lively & Communicative/ Reserved & Taciturn/ Anxious/ Apprehensive/ Timorous/ Irritable/ Introvert/ Extrovert, etc. E. ANY OTHER, SPECIFY 10 PHYSICAL EXAMINATION 10.1 GENERAL PHYSICAL EXAMINATION: Anaemia ……Jaundice…….. Cyanosis………Oedema (general/ partial)………… Lymph nodes (cervical, axiliary, inguinal, etc.)………………………. Blood pressure… …../….. mm of Hg ….Pulse rate………/ min. Temperature……°F Respiratory rate..… / min _____________________________________________________________________ *- especially change in mind & disposition during disease is to be highlighted. Also mention: 1. Are the intellectual functions, power of thought, memory or desire or ability for mental or bodily exercise weakened? 2. Are mental emotions of long continuance, or are they very transient? Whether patient suffers patiently or is inclined to weep, to be morose, passionate, despairing, greatly anxious or fearful etc. or whether the mind is remarkably affected in these respects by the disease? 10.2 REGIONAL EXAMINATION*: 75 Chronic bronchitis protocol Body Built (Obese/ lean/ stocky) Stature large/ small Weight Kg. (Increasing/decreasing/stationary) Gait Posture Deformities Complexion (Fair/ wheatish/ dark/ florid/ pale) Clean/dirty Look Premature old/ Childish/ young/ Senile Facial configuration & expression Scalp / Head Hair (colour & condition) Eyes Pupil Vision Ears Ear wax Dry/ fluid, fetid/ odorless Hearing Chin Jaw Nose Mouth Taste Lips Tongue Gums Breath (odour) Teeth Speech & voice Pulse Hand Palms Fingers (Clubbing) Nails Toes Thyroid Perspiration Location Physical properties Acrid, Bloody, Burning, Clammy, Cold, Warm, Diminished, Excessive, Odors, Oily, Staining, Sticky, Suppressed, absent SKIN Coldness General Partial (location) Heat, Warmth General Partial (location) Any growths (Tumuors, Exanthemata, Warts, Corns, Cysts etc) 76 Chronic bronchitis protocol Discoloration ______________________________________________________________________ ___ *- Give tick ( ) mark wherever applicable 10.3. SYSTEMIC EXAMINATION* [DETAILS MAY BE TAKEN ACCORDING TO RESEARCH PROTOCOL](Firstly and thoroughly the system under suspicion- Next other systems in turn, considering the important points only). Basically each system is examined by i. Inspection ii. Palpation iii. Percussion iv. Auscultation v. Special and Instrumental examination as and when necessary. Detail of system affected Respiratory system- Cardiovascular system- Nervous system- Gastro-intestinal system- Genito urinary system- Locomotor system Joints and bones- 11. LABORATORY INVESTIGATIONS (whichever applicable to the research project) (Including previous investigations got done by the patient, if any. Positive findings may be recorded in the relevant annexure of assigned problem) (Attach separate sheet) 12. DIAGNOSIS : 77 Chronic bronchitis protocol 13. ANALYSIS AND EVALUATION OF SYMPTOMS:- Causation Mental generals Physical generals (including side affinity, if any) Uncommon symptoms Particulars Common symptoms (Characteristic, Key Note, Peculiar sensations, Concomitants, Modalities etc.) Score 14. BASELINE SYMPTOM SCORE (Attach Baseline (document) 15. MIASMATIC ANALYSIS: Symptoms Psora Sycosis Syphilis Tubercular Conclusion-Dominant miasm: 16. TOTALITY OF SYMPTOMS:[PQRS* in respect of Mental/ Physical Generals & Particulars; Causation; Past history; Family history & Pathological changes] 17. SELECTION OF MEDICINE: (attach Repertorial sheet, wherever applicable) 17.1. - Repertorization- 78 Chronic bronchitis protocol Repertory used: Method of RepertorizationChapter Symptoms Selected Rubrics ________________________________________________________________________________ *- Peculiar, Queer, Rare symptoms 17.2 Repertorial analysis: 18. FIRST PRESCRIPTION: 18.1. Justification of the prescription 18.2. Prescription Date ………….. Name of medicine and potency ………………………..…. Dosage ……… Number of days………………. 18.3. General Supportive Care:[According to protocol ] 79 Chronic bronchitis protocol NOTE: - 1. Case taking should be in legible writing 2. No column should be left blank 3. NP- nothing particular 4. NK – not known signature signature investigator Incharge of the institute/unit 80 Chronic bronchitis protocol Form C2 Baseline Assessment Serial number __________ Site Code ______________________ Date _________________ Name of Patient ______________________________________ Sex: Male/Female _______________ Age Address ____________________________________________________________________________ ________ _________________________________________ Tel ___________________ e-mail ______________________ 1. HAS THE WRITTEN INFORMED CONSENT OF THE PATIENT BEEN TAKEN: Yes / No If ‘Yes’ then proceed further. 2. HISTORY OF CURRENT ILLNESS (Complete or circle correct response): Duration of productive cough : months). _______ (valid more than 3 Seasonal: summer/winter/rainy/change. 1. Symptom score at entry level Symptom/Score 0 1 1. Chronic Absen Cough t Severity Mild (irritating) Paroxysms nil 1 hr to 6 hrs [duration] 2. Expectorati Absen on t Difficulty in raising Easy Quantity Scanty Thin 2 4. Crackles Absen t Absen t Absen 3 4 12 hrs to 18 hrs Severe (spasmodic) 18 hrs to 24 hrs Present Moderate (distressing) 6 hrs to 12 hrs present Difficult Copious Thick Mucoid Transparent/ Translucent 3. Difficult respiration _______ days Frothy White Yellow Lumpy/ in shape of balls Purulent Greenish Mild exertion With cough Present Heavy exertion Present 81 Chronic bronchitis protocol t Total Total of Entry level score: ______________ [10-40] MILD: 10 to 15 MODERATE: 16 to 31 SEVERE:32 -40 HISTORY OF ATTACKS IN THE PREVIOUS YEARS 2. Duration of illness in years: ___________ 3. Duration of attacks of productive cough : _______ (valid more than 3 months) 4. Seasonal: summer/winter/rainy/change. _______ days HISTORY OF EXPOSURE TO POLLUTANTS 5. Smoking [ Active/Passive; Duration: ___________; No. of cigarettes per day ___________ ] 6. Environment (Air pollution)/Occupation 7. Respiratory infections 8. Familial factors 82 Chronic bronchitis protocol ROUTINE PHYSICAL EXAMINATION (7 ) General • General appearance (does the patient look healthy, unwell or ill, well cared for or neglected?) • Intelligence and educational level • Mental state • Expression and emotional state • Build and posture • Skin colour, cyanosis, anaemia, jaundice, pigmen tation • Temperature, pulse, respiration rate Eyes • Oedema of the lids • Gonjunctivae: anaemia, jaundice or inflammation • Pupils: size, equality, regularity, reaction to light, accommodation Mouth Pharynx • State of tonsils. Neck • Lymphatic glands Upper limbs • Fingernails: clubbing or koilonychia • Pulse: rate, rhythm, volume and character 83 Chronic bronchitis protocol • Axillae: lymph glands • Blood pressure Chest • Respiration: rate, depth and character • Position of trachea by palpation • Palpate respiratory movements • Estimate tactile vocal fremitus • Percuss the lungs • Auscultate the heart sounds • Auscultate the breath sounds Posteriorly (patient sitting) • Inspect and palpate respiratory movement • Estimate tactile vocal fremitus • Percuss the lung resonance • Auscultate the breath sounds • Estimate vocal resonance Abdomen • Hernial orifices • Palpation: tenderness, rigidity, hyperaesthesia, splashing, masses, liver, gallbladder, spleen, kidneys, bladder • Percussion: masses, liver, spleen, bladder 84 Chronic bronchitis protocol • Auscultation: bowel sounds, murmurs Lower limbs • General examination of legs and feet • Oedema of feet and ankles • Varicose veins • Joints: movement, pain and swelling Examination of excreta • Test urine for specific gravity, sugar, protein and blood. INVESTIGATIONS Spirometry: Normal values • FEV1 • FEV1/FVC • TLC • Residual Volume • Vital Capacity X-ray chest: Pathological: • Hb% • TLC • DLC • ESR • Sputum for AFB (3 consecutive days) • ELISA for Mycobacterium Tuberculosis 85 Chronic bronchitis protocol Enrolled into study: Yes / No. signature Signature Signature consultant Investigator 86 incharge of the institute/unit Chronic bronchitis protocol FORM D Follow up [at every visit] unique identifier- Site code/screening no./baseline assessment no./research case no./OPD regd no. Date _________________ Name of Patient ______________________________________ Sex: Male/Female _______________ Age Address ____________________________________________________________________________ ________ _________________________________________ Tel ___________________ e-mail ______________________ HISTORY OF CURRENT ILLNESS (Complete or circle correct response): 1. Symptom score at entry level Symptom/Score 0 1 Chronic Cough Absen t Severity Mild (irritating) Paroxysms nil 1 hr to 6 hrs [duration] Expectoration Absen 1 hr to 6 hrs t Difficulty in raising Easy Quantity Scanty Thin 2 Crackles Absen t Absen t Absen t 4 Present Moderate (distressing) 6 hrs to 12 hrs 6 hrs to 12 hrs Mucoid Transparent/ Translucent Difficult respiration 3 Frothy White 12 hrs to 18 hrs 12 hrs to 18 hrs Difficult Copious Thick Severe (spasmodic) 18 hrs to 24 hrs 18 hrs to 24 hrs Yellow Lumpy/ in shape of balls Purulent Greenish Mild exertion With cough Present Heavy exertion Present Total Total of Entry level score: ______________ [10-40] MILD: 10 to 15 MODERATE: 16 to 31 SEVERE:32 -40 87 Chronic bronchitis protocol INVESTIGATIONS Spirometry: Normal values • FEV1 • FEV1/FVC • TLC • Residual Volume • Vital Capacity X-ray chest: Pathological: • Hb% • TLC • DLC • ESR • Sputum for AFB (3 consecutive days) • ELISA for Mycobacterium Tuberculosis 88 Chronic bronchitis protocol 2. ROUTINE PHYSICAL EXAMINATION (7 ) General • Temperature, pulse, respiration rate Pharynx • Lymphatic glands • Pulse: rate, rhythm, volume and character • Axillae: lymph glands • Blood pressure Chest • Respiration: rate, depth and character • Position of trachea by palpation • Palpate respiratory movements • Estimate tactile vocal fremitus • Percuss the lungs • Auscultate the heart sounds • Auscultate the breath sounds Posteriorly (patient sitting) • Inspect and palpate respiratory movement • Estimate tactile vocal fremitus • Percuss the lung resonance • Auscultate the breath sounds 89 Chronic bronchitis protocol • Estimate vocal resonance MEDICAMENTS, Treatment Compliance to Homoeopathic treatment a) Medicines prescribed b) Continuation of treatment c) Name of the medicine if changed (Reasons for change) d) Number of doses taken Compliance to Instructions 1. Whether medicine taken regularly 2. How many times not taken on scheduled time 3. Any other medicines taken 4. Follow-up of general management (REF 6.2.6) Other symptoms of the patient as per initial case record: a) --------b) --------c) --------- Remarks, if any signature Signature Signature consultant Investigator 90 incharge of the institute/unit Chronic bronchitis protocol FORM E,F,G Assessment [at 3 months/ 6 months/at 9 months/15th/18th /21st/27th month /30th month/33rd month] unique identifier- Site code/screening no./baseline assessment no./research case no./OPD regd no. Date _________________ Name of Patient ______________________________________ Sex: Male/Female _______________ Age Address ____________________________________________________________________________ ________ _________________________________________ Tel ___________________ e-mail ______________________ 3. Symptom score at entry level Symptom/Score 0 1 Chronic Cough Absen t Severity Mild (irritating) Paroxysms nil 1 hr to 6 hrs [duration] Expectoration Absen 1 hr to 6 hrs t Difficulty in raising Easy Quantity Scanty Thin 2 Crackles Absen t Absen t Absen t 4 Present Moderate (distressing) 6 hrs to 12 hrs 6 hrs to 12 hrs Mucoid Transparent/ Translucent Difficult respiration 3 Frothy White 12 hrs to 18 hrs 12 hrs to 18 hrs Difficult Copious Thick Severe (spasmodic) 18 hrs to 24 hrs 18 hrs to 24 hrs Yellow Lumpy/ in shape of balls Purulent Greenish Mild exertion With cough Present Heavy exertion Present Total Total of Entry level score: ______________ [10-40] MILD: 10 to 15 MODERATE: 16 to 31 SEVERE:32 -40 91 Chronic bronchitis protocol INVESTIGATIONS Spirometry: Normal values • FEV1 • FEV1/FVC • TLC • Residual Volume • Vital Capacity X-ray chest: Pathological: • Hb% • TLC • DLC • ESR • Sputum for AFB (3 consecutive days) • ELISA for Mycobacterium Tuberculosis MEDICAMENTS, Treatment Compliance to Homoeopathic treatment a) Medicines prescribed b) Continuation of treatment c) Name of the medicine if changed (Reasons for change) d) Number of doses taken Compliance to Instructions 5. Whether medicine taken regularly 6. How many times not taken on scheduled time 7. Any other medicines taken 8. Follow-up of general management (REF 6.2.6) 92 Chronic bronchitis protocol Other symptoms of the patient as per initial case record: a) --------b) --------c) --------- Remarks, if any Symptom score at Entry level [n0]: _________________ Symptom score after 3 month follow-up [n3]:: __________ Difference in symptom score: ____________ (value in plus or minus) Overall response to treatment: Better (plus) / No response (zero) / Worse (minus). Improvement rate: [(n0 - n3) /0.4] % : ____________ (value in plus or minus). signature Signature Signature consultant Investigator 93 incharge of the institute/unit Chronic bronchitis protocol FORM H Assessment [at 12 months /2yrs/3yrs] unique identifier- Site code/screening no./baseline assessment no./research case no./OPD regd no. Date _________________ Name of Patient ______________________________________ Sex: Male/Female _______________ Age Address ____________________________________________________________________________ ________ _________________________________________ Tel ___________________ e-mail ______________________ 4. Symptom score at entry level Symptom/Score 0 1 Chronic Cough Absen t Severity Mild (irritating) Paroxysms nil 1 hr to 6 hrs [duration] Expectoration Absen 1 hr to 6 hrs t Difficulty in raising Easy Quantity Scanty Thin 2 Crackles Absen t Absen t Absen t 4 Present Moderate (distressing) 6 hrs to 12 hrs 6 hrs to 12 hrs Mucoid Transparent/ Translucent Difficult respiration 3 Frothy White 12 hrs to 18 hrs 12 hrs to 18 hrs Difficult Copious Thick Severe (spasmodic) 18 hrs to 24 hrs 18 hrs to 24 hrs Yellow Lumpy/ in shape of balls Purulent Greenish Mild exertion With cough Present Heavy exertion Present Total Total of Entry level score: ______________ [10-40] MILD: 10 to 15 MODERATE: 16 to 31 SEVERE:32 -40 94 Chronic bronchitis protocol INVESTIGATIONS Spirometry: Normal values • FEV1 • FEV1/FVC • TLC • Residual Volume • Vital Capacity X-ray chest: Pathological: • Hb% • TLC • DLC • ESR • Sputum for AFB (3 consecutive days) • ELISA for Mycobacterium Tuberculosis MEDICAMENTS, Treatment Compliance to Homoeopathic treatment a) Medicines prescribed b) Continuation of treatment c) Name of the medicine if changed (Reasons for change) d) Number of doses taken Compliance to Instructions 9. Whether medicine taken regularly 10. How many times not taken on scheduled time 11. Any other medicines taken 12. Follow-up of general management (REF 6.2.6) 95 Chronic bronchitis protocol Other symptoms of the patient as per initial case record: a) --------b) --------c) --------- Remarks, if any Symptom score at Entry level [n0]: _________________ Symptom score after 12 month follow-up [n12]:: __________ Difference in symptom score: ____________ (value in plus or minus) Overall response to treatment: Better (plus) / No response (zero) / Worse (minus). Improvement rate: [(n0 – n12) /0.4] % : ____________ (value in plus or minus). signature Signature Signature consultant Investigator 96 incharge of the institute/unit Chronic bronchitis protocol STUDY REPORTING PROFORMA I 1) MONTHLY REPORTING PROFORMA . Name of the Institute/Unit 2) Title of Study 3) Name of Reporting Officer 4) No. of cases Attended O.P.D. T M F New Old Total 5) No. of cases Registered so far since Inception 6) No. of cases screened 7) No. of cases given informed consent 8) No. of cases Investigated for Diagnosis X-ray PFT 9) No. of cases with confirmed diagnosis. 10) No. of cases found suitable for inclusion into the study. 11) No. of old cases followed up a) No. of cases excluded. b) No. of cases dropped out. c) No. of cases discontinued from study d) No. of cases referred 12) Registration no. of case records enclosed 13) 1. No. of Visits Consultant 2. No. of patient seen New Old T M F Note- Enclose one copy of one case record of chronic bronchitis registered during the reporting month & follow-up sheet for the case record submitted in the previous monthly report.. 97 Chronic bronchitis protocol Follow-up action report in respect of Cases not cleared in i) Screening, ii) Base line assessment and the cases withdrawn from the study Project Total no. of cases loss of follow up S.No. Ref.No. Name Age Sex Screened Base line Signature Investigator Withdrawn Reason Action taken Signature Incharge of the Instt./Unit 98 Rx Institute Chronic bronchitis protocol Study Reporting Proforma II INTERIM REPORT ( After 3 months) 1 INTRODUCTION 1.1. Title of the Study: 1.2. Name of the Institute/Unit: 1.3. Period of Interim Report: 1.4. Primary Objective of the Study: To ascertain therapeutic efficacy of Homoeopathic Medicine(s) in the management of Chronic Bronchitis. 1.5. Secondary Objective of the Study: To ascertain the role of Homoeopathic medicine and to establish verified characteristic symptoms of medicine used. To assess the role of homoeopathic medicines in reversing the pathological changes due to Chronic Bronchitis. Determine the most useful strategy for management of the differing intensity. To check the progression to complications. To prevent the relapse. 1.6 No. of cases Attended O.P.D. T M F T M F New Old Total 1.7 No. of cases Registered so far since Inception 1.8. No. of Cases Studied: 1.9. Staff Engaged in the Project: Name Qualification Designation i) ii) iii) iv) v) 1.10. Number of subject presenting with following symptoms and signs: New Old Symptoms/ signs 99 Chronic bronchitis protocol T 1.11 M F T M F Examination findings: i) ii) iii) iv) v) 1.10- pathological findings – New 1. 2. 3. 4. 5. Old X-ray findingPFTany other finding- 2- material– 2.1- total no. of research cases T M F 1. Screened 2. included in study 3. Excluded 4. dropped out 5. loss to follow-up 6. Withdrawn 2.2- age distribution New 100 Old Chronic bronchitis protocol 1. 40-50 yrs 2. 50-60 yrs 3. 60-70 yrs 4. 5. 2.3- duration of complaintsNew Old New Old 1. range- Minimum ______________ 2. Maximum ___________________ 3. 3 months- to less than 6 months 4. 6 months to less than 1 yr 5. 1 yr to less than 5 yr 6. 6 yr to less than 10 yr 7 11 yr to less than 15 yr 8 16 yr to less than 20 yr 9 20 yrs and above 2.4- predisposition1. 2. smoking exposure to allergens 2.5- clinical types of chronic bronchitis 1. simple 2. mucopurulent 2.6- baseline information & post treatment symptom score baseline 1. 10-15 2. 16-31 3 32-40 2.7- reduction in baseline symptom score after treatment T 1. more than 1 and less than 5 2. b/w 5 & 6 less than 8 3 more than 8 & less than 10 4 more than 10 & less than 15 2.8- improvement in pathological /examination findingsBefore Treatment 1. decrease in crackles 2. change in X-ray finding a normal b abnormal 3 changes in PFT post treatment M After Treatment 3- basis of prescription New 1. 2. 3 4 mental symptoms physical characteristics repertorial totality 101 Old Chronic bronchitis protocol 3.1- duration of treatment New Old New Old 1. Minimum 2. Maximum 3 0-3 months 4 3-6months 5 6-9 months 6 9months to 1 yr 7 more than 1 year 3.2- improvement indices— I degree of improvement1. 2. 3 Marked Moderate Mild II III IV Worsened Static Referred for other treatment- 3.3.1. Sl. No. Name of Drug with Potency & Dosage Indication No. of cases Medicine Prescribed NO. OF CASES Improvement Mild Moderate 3.3.2. Name of Drug Clinical symptoms improved No. of cases 4. Relapse Relapse with intensity Before and After Treatment Intensity Before Treatment No of Cases Intensity After Treatment No of No of Cases Cases Mild Moderate No of Cases Severe Mild Moderate Severe 5. Progression to complications. Complications Name of Medicine(s) with No. of cases potency 102 Marked Chronic bronchitis protocol Number of cases referred for other therapy/ clinical failure Baseline Score Duration of Score At Time No.of Medicines Used Treatment Of Referral Age Of Case Number of adverse events Name of Duration of Management adverse Treatment Done event Name of Medicines Response Used if homoeopathic Treatment Management The most useful strategy for management of the differing intensity 6. 6.1. Problems faced by Inst/Unit during implementation of study. 6.2. Suggestions for rectifying these problems 6..3. Any Special Achievement Signature Signature Investigator incharge of the institute/unit 103 to Chronic bronchitis protocol REPORTING PROFORMA III INTERIM REPORT ( ( 6 months / 9months / 12 months/2yrs/3yrs )) (To be submitted to Hqrs.) 1 INTRODUCTION 1.1. Title of the Study: 1.2. Name of the Institute/Unit: 1.3. Period of Interim Report: 1.4. Primary Objective of the Study: To ascertain therapeutic efficacy of Homoeopathic Medicine(s) in the management of Chronic Bronchitis. 1.5. Secondary Objective of the Study: To ascertain the role of Homoeopathic medicine and to establish verified characteristic symptoms of medicine used. To assess the role of homoeopathic medicines in reversing the pathological changes due to Chronic Bronchitis. Determine the most useful strategy for management of the differing intensity. To check the progression to complications. To prevent the relapse. 1.6 No. of cases Attended O.P.D. T M F T M F New Old Total 1.7 No. of cases Registered so far since Inception 1.8. No. of Cases Studied: 1.9. Staff Engaged in the Project: Name Qualification i) ii) iii) iv) 104 Designation Chronic bronchitis protocol v) 1.10. 1.11 Number of subject presenting with following symptoms and signs: New Old Symptoms/ signs T M F T M F Examination findings: i) ii) iii) iv) v) 1.10- pathological findings – New 1. 2. 3. 4. 5. Old X-ray findingPFTany other finding- 2- material– 2.1- total no. of research cases T 1. 2. Screened included in study 105 M F Chronic bronchitis protocol 3. Excluded 4. dropped out 5. loss to follow-up 6. Withdrawn 2.2- age distribution New Old New Old New Old 1. 40-50 yrs 2. 50-60 yrs 3. 60-70 yrs 4. 5. 2.3- duration of complaints1. range- Minimum ______________ 2. Maximum ___________________ 3. 3 months- to less than 6 months 4. 6 months to less than 1 yr 5. 1 yr to less than 5 yr 6. 5 yr to less than 10 yr 7 10 yr to less than 15 yr 8 15 yr to less than 20 yr 9 20 yrs and above 2.4- predisposition1. 2. smoking exposure to allergens 2.5- clinical types of chronic bronchitis 1. simple 2. mucopurulent 2.6- baseline information & post treatment symptom score baseline 1. 10-15 2. 16-31 3 32-40 2.7- reduction in baseline symptom score after treatment T 1. more than 1 and less than 5 2. b/w 5 & 6 less than 8 3 more than 8 & less than 10 4 more than 10 & less than 15 2.8- improvement in pathological /examination findingsBefore Treatment 1. decrease in crackles 2. change in X-ray finding a normal b abnormal 3 changes in PFT 3- basis of prescription 106 post treatment M After Treatment Chronic bronchitis protocol New 1. 2. 3 4 Old mental symptoms physical characteristics repertorial totality 3.1- duration of treatment New Old New Old 1. Minimum 2. Maximum 3 0-3 months 4 3-6months 5 6-9 months 6 9months to 1 yr 7 more than 1 year 3.2- improvement indices— I degree of improvement1. 2. 3 Marked Moderate Mild II III IV Worsened Static Referred for other treatment- 3.3.1. Sl. No. Name of Drug with Potency & Dosage Indication No. of cases Medicine Prescribed NO. OF CASES Improvement Mild Moderate 3.3.2. Name of Drug Clinical symptoms improved No. of cases 4. Relapse Relapse with intensity Before and After Treatment Intensity Before Treatment No of Cases Intensity After Treatment No of No of Cases Cases Mild Moderate Mild Moderate Severe 107 No of Cases Severe Marked Chronic bronchitis protocol 5. Progression to complications. Complications Name of Medicine(s) with No. of cases potency Number of cases referred for other therapy/ clinical failure Baseline Score Duration of Score At Time No.of Medicines Used Treatment Of Referral Age Of Case Number of adverse events Name of Duration of Management adverse Treatment Done event Name of Medicines Response Used if homoeopathic Treatment Management The most useful strategy for management of the differing intensity 6. 6.1. Problems faced by Inst/Unit during implementation of study. 6.2. Suggestions for rectifying these problems 6..3. Any Special Achievement Signature Signature Investigator incharge of the institute/unit 108 to Chronic bronchitis protocol REPORTING PROFORMA IV ( ( consolidated report)) (To be submitted to Hqrs.) 1 INTRODUCTION 1.1. Title of the Study: 1.2. Name of the Institute/Unit: 1.3. Period of Interim Report: 1.4. Primary Objective of the Study: To ascertain therapeutic efficacy of Homoeopathic Medicine(s) in the management of Chronic Bronchitis. 1.5. Secondary Objective of the Study: To ascertain the role of Homoeopathic medicine and to establish verified characteristic symptoms of medicine used. To assess the role of homoeopathic medicines in reversing the pathological changes due to Chronic Bronchitis. Determine the most useful strategy for management of the differing intensity. To check the progression to complications. To prevent the relapse. 1.6 No. of cases Attended O.P.D. T M F T M F New Followed up Total 1.7 No. of cases Registered so far since Inception 1.8. No. of Cases Studied: 1.9. Staff Engaged in the Project: Name Qualification i) ii) iii) iv) v) 109 Designation Chronic bronchitis protocol 1.10. 1.11 Number of subject presenting with following symptoms and signs: New Old Symptoms/ signs T M F T M F Examination findings: i) ii) iii) iv) v) 1.10- pathological findings – New 1. 2. 3. 4. 5. Old X-ray findingPFTany other finding- 2- material– 2.1- total no. of research cases T 1. 2. 3. 4. 5. 6. Screened included in study Excluded dropped out loss to follow-up Withdrawn 110 M F Chronic bronchitis protocol 2.2- age distribution New Old New Old New Old 1. 40-50 yrs 2. 50-60 yrs 3. 60-70 yrs 4. 5. 2.3- duration of complaints1. range- Minimum ______________ 2. Maximum ___________________ 3. 3 months- to less than 6 months 4. 6 months to less than 1 yr 5. 1 yr to less than 5 yr 6. 5 yr to less than 10 yr 7 10 yr to less than 15 yr 8 15 yr to less than 20 yr 9 20 yrs and above 2.4- predisposition1. 2. smoking exposure to allergens 2.5- clinical types of chronic bronchitis 1. simple 2. mucopurulent 2.6- baseline information & post treatment symptom score baseline 1. 10-15 2. 16-31 3 32-40 2.7- reduction in baseline symptom score after treatment T 1. more than 1 and less than 5 2. b/w 5 & 6 less than 8 3 more than 8 & less than 10 4 more than 10 & less than 15 2.8- improvement in pathological /examination findingsBefore Treatment 1. decrease in crackles 2. change in X-ray finding a normal b abnormal 3 changes in PFT post treatment M After Treatment 3- basis of prescription New 1. 2. 3 mental symptoms physical characteristics repertorial totality 111 Old Chronic bronchitis protocol 4 3.1- duration of treatment New Old New Old 1. Minimum 2. Maximum 3 0-3 months 4 3-6months 5 6-9 months 6 9months to 1 yr 7 more than 1 year 3.2- improvement indices— I degree of improvement1. 2. 3 Marked Moderate Mild II III IV Worsened Static Referred for other treatment- 3.3.1. Sl. No. Name of Drug with Potency & Dosage Indication No. of cases Medicine Prescribed NO. OF CASES Improvement Mild Moderate 3.3.2. Name of Drug Clinical symptoms improved No. of cases 4. Relapse Relapse with intensity Before and After Treatment Intensity Before Treatment No of Cases Intensity After Treatment No of No of Cases Cases Mild Moderate No of Cases Severe Mild Moderate Severe 5. Progression to complications. Complications Name of Medicine(s) with No. of cases 112 Marked Chronic bronchitis protocol potency Number of cases referred for other therapy/ clinical failure Baseline Score Duration of Score At Time No.of Medicines Used Treatment Of Referral Age Of Case Number of adverse events Name of Duration of Management adverse Treatment Done event Name of Medicines Response Used if homoeopathic Treatment Management The most useful strategy for management of the differing intensity 6. 6.1. Problems faced by Inst/Unit during implementation of study. 6.2. Suggestions for rectifying these problems 6..3. Any Special Achievement Signature Signature Investigator incharge of the institute/unit 113 to Chronic bronchitis protocol 114