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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA, ANNEXURE-II APPLICATION FOR REGISTRATION OF SUBJECT FOR DISSERTATION 1. NAME OF THE DR. SHIVENDRA KUMAR PATEL CANDIDATE & ADDRESS DEPT OF HOM. PHARMACY, FATHER MULLER HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, UNIVERSITY ROAD, DERALAKATTE, MANGALORE-574160 (KARNATAKA) PERMANENT ADDRESS S/o MR.K.K.PATEL HOUSING BOARD COLONY DIST. MANDLA MADHYA PRADESH 2. NAME OF THE FATHER MULLER HOMOEOPATHIC INSTITUTION MEDICAL COLLEGE AND HOSPITAL, DERALAKATTE, MANGALORE. 3. COURSE OF THE STUDY & M.D.(HOM) SUBJECT 4. DATE OF ADMISSION TO THE COURSE 5. HOMOEOPATHIC PHARMACY 06-06-2009 TITLE OF THE TOPIC EFFECT OF HOMOEOPATHIC MEDICINE ON HEART 1 6. BRIEF RESUME OF THE INTENDED WORK 6.1 Need for study Homoeopathy as a system of medicine has been found effective in the cure of the sick, with its unique principle of “Similia Similibus Curentur”. But it is an unfortunate impression that Homoeopathy is static and no research is being done or advance made. So in the light of various advances and differing circumstances, we may have to reorient ourselves and improve our methods, without moving away from the basic Homoeopathic principles. Since Hahnemannian time the Homoeopathic phenomenon has been challenging scientists, who even today cannot understand it or describe it.1 So today’s need is to scientifically support the hypothesis and provide scientific base to homoeopathic treatment. Since no generally accepted mechanism of action of homoeopathy exists, the requirements for accepting such evidence will be higher than for more ‘plausible’ therapies for improving the everyday practice of homoeopathy.2 Current study is needed as there is a need for scientific research into homoeopathy which has fundamental, practical and social aspects. A fundamental question is whether homoeopathic ultra molecular medicine work? And if so how they act when no molecule of the initial substance is present. The question of which diseases respond to homoeopathic treatment is of practical importance.3 So this study characterizes the effect of homoeopathic medicines through the changes which will be produced in human heart rate, rhythm & conduction. Homoeopathy has very much effective role in the treatment related with variations in heart rate, rhythm & conduction. Current study is to prove the efficacy of homoeopathy medicine in altering the human heart rate, rhythm & conduction and is also to prove the findings of materia medica related with cardiac system. So, this study seeks to test the action of Homoeopathic medicine on heart and provides a scientific foundation for homoeopathy and to improve the efficacy of homoeopathy in every day practice. 2 6.2 Review of literature. Heart It is an organ that pumps blood received from veins into arteries throughout the body. It is positioned in the chest behind the sternum. The normal heart is about the size of a closed fist, and weighs about 10.5 ounces. It is four-chambered with a right atrium and ventricle, and an anatomically separate left atrium and ventricle.4 As current study is on heart rate, rhythm and conduction, it will be better if they are explained briefly. Heart rate: Heart rate is the number of heart beats per unit time, usually per minute. The heart rate is based on the number of contractions of the ventricles (the lower chambers of the heart). The heart rate may be too fast tachycardia or too slow bradycardia. The pulse is bulge of an artery from the wave of blood coursing through the blood vessel as a result of the heart beat. The pulse is often taken at the wrist to estimate the heart rate. In human, normal resting heart rate is about 70/min (65-75/min) and slightly higher in female (5beats/min.). Classically heart rate is taken to be 72/min. It is high in new born (120-130/min) and declines with age. It is lower in athletes. Increase in is heart rate is called tachycardia and a reduction is bradycardia. Conditions in which heart rate is increased are: Tachycardia: Tachycardia is a resting heart rate more than 100 beats per minute. This number can vary, as smaller people and children have faster heart rates than average adults. (1) Physiological:- (a) Muscular exercise (up to 180-200/min) (b) Emotional excitement (c) High environmental temperature (d) High altitude. (2) Pathological: Fevers (roughly 10 beats/10F or 18/10C increase), Hemorrhagic shock, Hyperthyroidism, Cardiac arrhythmias. 3 Conditions in which heart rate is decreased are: Bradycardia: Bradycardia is defined as a heart rate less than 60 beats per minute although it is seldom symptomatic until below 50 bpm when a human is at total rest.5 (1) Physiological:- In sleep heart rate is reduced by about 10 beats/min., and also in some emotions e.g. grief (2) Pathological:- Myxoedema, Addison’s disease, Heart block, Enteric fever6 Arrhythmia: Arrhythmias are abnormalities of the heart rate and rhythm (sometimes felt as palpitations). They can be divided into two broad categories: fast and slow heart rates. Some cause few or minimal symptoms. Others produce more serious symptoms of light-headedness, dizziness and fainting. Rhythm Normal sinus rhythm is the reference physiological rhythm of the heart. In normal sinus rhythm, the ‘p’ wave is negative in lead aVR and positive in lead-II.7 Abnormal rhythm occur as primary and secondary disorders The primary disorder of rhythm: It is classified into 2-major categories. a. Disturbance of impulse formation b. Disturbance of impulse conduction (A) Disturbance of impulse formation: (1) Sinus rhythm : - Sinus arrhythmia - Sinus tachycardia - Sinus bradycardia (2) Ectopic atrial rhythms - Atrial extra systole - Paroxysmal atrial tachycardia - Atrial fibrillation - Atrial flutter 4 (3) A.V. nodal rhythm - A.V. nodal extra systole. - Extra systolic paroxysmal - A.V nodal tachycardia - Idio nodal tachycardia (4) Ventricular rhythms - Ventricular extra systole - Extra systolic ventricular tachycardia - Idio ventricular tachycardia - Ventricular fibrillation - Ventricular parasystole (B) Distribution of impulse conduction : - SA block - AV block - The Wolf Parkinson White syndrome - Reciprocal rhythms The secondary disorder of rhythm : - Escape rhythm - Atrial escape - AV nodal escape - Ventricular escape - AV dissociation - Phasic aberrant ventricular conduction There are three fundamental aspects to every cardiac rhythm. 1.The rhythm has an anatomical origin 2.The rhythm has a discharge sequence 3.The rhythm has a conduction sequence.8 Conduction The speed with which electrical impulse conduct through different parts of the heart varies. For example conduction is slowest through the AV node and fastest 5 through the purkinje fibers. The relatively slow conduction speed through the AV node is of functional importance because it allows the ventricle time to fill with blood before the signal for cardiac contraction arrive. In addition to conductivity a major electrical feature of the heart is automaticity.9 Normal conduction mechanism The rate and rhythm of the heart are controlled by sino atrial node. The sinus impulse leaves the SA node and spread through the atrial muscle. This atrial activation is reflected by P wave of the electrocardiogram. The sinus impulse eventually reaches the AV node. After a delay at the AV node the impulse travel down the bundle of His, bundle branches and purkinje network system. The bundle of His passes horizontally to the left from the AV node, pierces the membranous inter ventricular septum and divides into right and left bundle branches. These pass down on either side of the muscular interventricular septum and finally divided into the purkinje network of fibers, which proceed vertically to the surface of the heart from the endocardium to the epicardium. The SA node is mainly under the influence of the vagus nerve.10 Disorder of conduction - Sinus- atrial block - Atrio ventricular block - Complete AV block - Bundle branch block - Pre excitation.11 Control of heart rhythmicity Control of heart rhythmicity and impulse conduction is done by the cardiac nerves. The sympathetic and parasympathetic nerves. The heart will supplied with both sympathetic and parasympathetic nerves (the vagi) which are distributed mainly to the SA and AV nodes, to a lesser extent to the muscles of the two atria and very little directly to the ventricular muscles. The sympathetic nerves conversely, are distributed to all parts of the heart, with strong representation to the ventricular muscles as well as to all the other areas. 6 Effect of sympathetic stimulation on cardiac rhythm and conduction :Sympathetic stimulation causes essentially the opposite effects on the heart, to those caused by vagal stimulation as follows: 1) It increases the rate of sinus nodal discharge. 2) It increases the rate of conduction as well as the level of excitability in all portion of heart. 3) It increases greatly the force of contraction of all the cardiac musculature, both atrial and ventricular.12 6.3 Objectives of the study a. To study the effect of a homoeopathic medicine in biological system. b. To know the efficacy of homoeopathic medicines on heart rate, rhythm & conduction 7. MATERIALS AND METHODS 7.1 Source of data o Drug: Digitalis 6x & 30c o Placebo: Ethyl alcohol: Rectified spirit 60 OP o 30 healthy human volunteers: All 30 healthy human beings of similar age group are selected randomly from the college campus. o E.C.G. machine: 7.2 Method of collection of data. Drug: Drugs will be taken from the Father Muller Homoeopathic Pharmaceutical Division. Base line: In first session, nothing will be given to the subject Placebo: In second session homeopathic solvent (ethyl alcohol) will be given to the subject E.C.G. machine: Heart rate variation will be checked with the help of E.C.G. so as to get a graphic record of voltage changes during the electrical activity of heart.13 The materials and methods used for the study. 1) Materials for study: Digitalis 6x & 30c 30 healthy volunteers E.C.G.{electro cardio graph}machine Ethyl alcohol: Rectified spirit 60 OP Purified water 7 2) Method of study: The study will be conducted in P.G. pharmacy lab of Father Muller Homoeopathic Medical College and Hospital, Mangalore. ECGs will be recorded from 30 healthy volunteers using E.C.G. machine during three intervals of 24hrs on alternate days, to allow a day to rest between recording sessions. The following will be the sequence of measurements : First session: Nothing will be given to the subject and ECG will be taken at three different intervals of time (morning, afternoon, evening). Second session: 10 drops of the Homeopathic solvent (placebo) will be dissolved in 50ml of water and taken at the rate of 5ml thrice a day. ECG will be taken at three different intervals of time (morning, afternoon, evening). ECG will be recorded half an hour after taking the placebo. Third session: The Homoeopathic medicine Digitalis 6x for 15 people & Digitalis 30c for 15 people will be given. 10 drops will be dissolved in 50ml of water and taken at the rate of 5ml thrice a day. Again ECG will be taken at three different intervals of time (morning, afternoon, evening). ECG will be recorded half an hour after taking the medicine. E.C.G thus recorded on all three sessions will be tabulated and changes in the heart rate, rhythm & conductions will be noted. Research Hypothesis. Homoeopathic medicines are capable to produce variation in cardiac activity. Null Hypothesis. Homoeopathic medicines are not capable to produce variation in cardiac activity. 7.3 Does the study require any interventions to be conducted on patients, or other humans (or animals)? If so please describe briefly. Yes, study requires investigation to be done. 7.4 Has of ethical clearance been obtained from your Institution in case of 7.3. Yes, enclosed 8 8. LIST OF REFERENCES 1. Zacharis Carlos Renato, Implication of contaminants to scientific research in homoeopath, B.H.J., jan.95, vol.84, p:3-5 2. Linde W, Melchart D., jonas B. , Hornung J. ,way to enhance the quality and acceptance of clinical and laboratory studies in homeopath, British homoeopathic journal, jan.94, vol.83, p:3-7 3. Vanberckel J.A.C.M., A pilot study evaluating the efficacy of homoeopathic in daily practice, British homeopathic journal, jan.93, vol.82, 9-15 4. www.medterms.com 5. Mcardle William d., Katch frank i., Katch victor. , Essentials of exercise physiology, R.R.donnelly & sons-Willard, 3rd edition 2006, p:672 6. Subrahmanyam Sarada, Madhavankutty k. text book of human physiology, 6th edition, 2004, p:146 7. Goldberger Aryl. , clinical electrocardiography a simplified approac, Elsevier, a division of reed Elsevier India pvt.ltd. ,7th edition, 2007, p:157 8. Schamroth Leo, an introduction to electro cardio grap, rekha printer pvt.ltd. , 7th edition, 1990, p:322-24 9. Goldberger Aryl., clinical electrocardiography a simplified approach, Elsevier, a division of reed Elsevier India pvt.ltd. ,7th edition, 2007, p:5 10. Schamroth Leo, an introduction to electro cardio grapy, rekha printer pvt.ltd. , 7th edition, 1990, p:321-322 11. Julian Desmond G., Coloan J. Campbell, Mclenachan Jamesm, cardiology, WB saunders co. Ltd. , 7th edition, 1998, p:202-08 12. Guyton & hall, medical physiolog, Elsevier a division of reed Elsevier India pvt. Ltd. ,first printed in India, 2006, p:121-22 13. Mcardle William d., Katch frank i., Katch victor, Essentials of exercise physiology, R.R.donnelly & sons-Willard, 3rd edition 2006, p:342 9 9. SIGNATURE OF THE CANDIDATE 10. REMARKS OF THE GUIDE 11. 11.1 NAME AND DR. PRAVAS. K. PAL, BHMS, MD(HOM) DESIGNATION OF THE HOD AND PROFESSOR, GUIDE (In block letters) DEPT. OF HOMOEOPATHIC PHARMACY, FATHER MULLER HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, DERALAKATTE, MANGALORE. 11.2 SIGNATURE 11.3 CO-GUIDE (IF ANY) 11.4 SIGNATURE 11.5 HEAD OF THE DR. PRAVAS .K. PAL, BHMS, MD(HOM) DEPARTMENT HOD AND PROFESSOR, DEPT. OF HOMOEOPATHIC PHARMACY, FATHER MULLER HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, DERALAKATTE, MANGALORE 11.6 SIGNATURE 12 12.1 REMARKS OF THE CHAIRMAN & PRINCIPAL 12.2 SIGNATURE 10