Download PROFORMA FOR REGISTRATION OF SUBJECT FOR

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1.
Name of the Candidate and
Address
FARZANA ANJUM
P.G. SCHOLAR,
DEPARTMENT OF ILMUL QABALAT WA
AMRAZE NISWAN,
NATIONAL INSTITUTE OF UNANI MEDICINE,
KOTTIGEPALYA, MAGADI MAIN ROAD,
BANGALORE-91.
2.
Name of the Institution
NATIONAL INSTITUTE OF UNANI MEDICINE ,
BANGALORE.
3.
Course of the study and subject
M.S. (UNANI),
ILMUL QABALAT WA AMRAZE NISWAN.
4.
03.11.2010 (BATCH 2010-2011)
5.
Date of the Admission to the
course
Title of the topic
6.
Brief resume of the intended work:
6.1
Need for the Study:
Hirsutism is defined as excessive terminal hair on face or body in woman, and it
is a sensitive marker for increased androgen production.1 Incidence of Hirsutism is 10%,2
and is present in about 70% of patients of polycystic ovarian disease. Skin 5 alpha
reductase activity largely determines the presence and absence of hirsutism, which is
influenced by racial characteristics.3 In India it is found 10.5 % in Kashmir. 4
Hyperandrogenism, infertility and endometrial hyperplasia are common
consequences of polycystic ovarian syndrome.5Among this Hirsutism may be distressing
for a woman and deserves at least a cursory evaluation. Hirsute woman commonly present
to gynaecologist, endocrinologists, and dermatologists and are evaluated by each group.6
Hirsutism is usually treated by hormonal pills and antiandrogens in conventional
medicine but they have got their own side effects. In Unani system of medicine various
drugs are available that can be used for treatment of hirsutism. Keeping this fact in view it
has been decided to conduct a clinical trial to evaluate the efficacy of post darakht neem
(Bark of Azadirachta indica) and zanjabeel (Zingiber officinalis) on hirsutism in polycystic
ovarian disease.
6.2
Review of literature:
Hyperandrogenemia with or without hyperandrogenism along with
oligomenorrhoea are the hallmark features of polycystic ovarian syndrome. An association
between insulin resistance and hirsutism has been known for decades. It is generally
accepted that 50 to 80 % of women with polycystic ovarian syndrome have at least some
insulin resistance. A correlation between serum insulin and androgen levels has been
CLINICAL EVALUATION OF EFFICACY OF
POST DARAKHT NEEM (Bark of Azadirachta
indica) AND ZANJABEEL (Zingiber officinalis)
ON HIRSUTISM IN POLYCYSTIC OVARIAN
DISEASE.
confirmed in many studies. 7
In authentic unani books, Hirsutism is mentioned as a complication of ehtebase
tams along with virilism due to sue mizaj barid and samane mufarrat. This is due to
dominance of khilte balgham which increases the viscosity of khoon haiz and forms sudda
ultimately leads to ehtabase tams or qillate tams. When this blood is not expelled from the
uterus returns back in to circulation, the process when occurs for a long time give rise to
hirsutism.8,10,11
In polycystic ovarian syndrome various drugs are available that not only reduces the
obesity, regularize menstruation and prevent further growth of hair. Among these Post
darakht neem kohna (Bark of Azadirachta indica), Zanjabeel (Zingiber officinalis) having
the musaffi khoon, mulattif khoon, mufatteh suddad, mudir haiz, antihyperglycemic,
antitumorigenic and antioxidant properties have been selected to explore the efficacy of
these drugs scientifically.12,14
6.3
Objectives of the study:
 To clinically evaluate the efficacy and safety post darakht neem (bark of
Azadirachta indica) and Zanjabeel (Zingiber officinalis) in management of
hirsutism in polycystic ovarian syndrome.
7.
MATERIAL AND METHODS
7.1
Source of Data:
Patients attending the female OPD and IPD, Department of Ilmul Qabalat wa Amraze
Niswan , NIUM, Bangalore.
7.2
Method of Collection of data:
 History taking and clinical examination.
 Laboratory investigations.
Selection Criteria:
Patients of Hirsutism clinically assessed and confirmed by investigations will be included
in the study after obtaining their voluntary consent.
Inclusion Criteria:
 Married and unmarried patients in the age group 14 to 40 years.
 Patients with hirsutism due to polycystic ovarian disease.
 Patients with menstrual irregularities like oligomenorrhoea and amenorrhoea.
Exclusion Criteria:
 Pregnant and lactating women.
 Patients with menorrhagia.
 Patients with thyroid dysfunction, adrenal dysfunction, virilism, ovarian tumours.
 Patients with systemic illness and malignancy.
 Patients on hormonal and steroid therapy.
Sample size:
 Total Patients 40.
 Test Group - 20 patients.
 Control Group -20 patients.
Study design:
Randomized single blind standard controlled study.
Subjective Parameters:
 Hirsutism.
Objective Parameters:
 Modified Ferrimen Gallwey Score (≥ 6).13
 Lipid profile.
 Pelvic ultrasonography.
 Serum free testosterone.
 Serum insulin.
 Serum LH and FSH.
Duration of Study: One and Half Year.
Duration of protocol therapy: 3 months.
For Test Group:
Unani formulation: 8,9,12
Post darakht neem kohna (Bark of Azadirachta indica) 24 gms
Zanjabeel (Zingiber officinalis)
04 gms
Qand syah
24 gms
Method of Preparation, Dosage, administration:
Both drugs are cleaned in their respective quantities, after crushing decoction of 28 grams
of unani formulation will be prepared in 375 ml of water, qand syah 24 grams is mixed and
given orally twice daily before meal for 3 months, stop during menstruation.
For control group:
Standard drug: Tab. Cyproterone acetate 2mg + Ethinyl oestradiol 0.035 mg (tab.
Krimson 35) once a day for 3 months, stop during menstruation.
Follow Up:
 During treatment: once in 15 days.
 After treatment: once in a month for 3 consecutive months.
Withdrawal Criteria:
 Failure to follow protocol therapy.
 The cases in which adverse drug reaction is noticed.
Informed Consent:
Patients fulfilling the inclusion criteria mentioned above will be given information
sheet having details regarding the nature of study, the drugs to be used. Patients will be
given enough time to go through the study details mentioned in the information sheet. They
will be given the opportunity to ask any question and if they agree to participate in the
study, they will be asked to sign the informed consent form.
Assessment of Efficacy:
 Primary outcome measures- changes in modified Ferrimen Gallwey score, serum
free testosterone, and serum insulin.
 Secondary outcome measures- changes in pelvic scan, lipid profile, LH and FSH.
Assessment of safety :
 Clinical symptoms.
 Adverse drug reaction.
 Investigations.
Adverse effects documentation :
Any adverse reaction of the drug will be documented.
Documentation :
The record will be submitted to the Department after completion of study.
Statistical Analysis:
The statistical analysis will be restricted to those patients who will complete the
study. Analysis of data will be made by appropriate statistical test.
7.3
Does the study require any investigations or interventions to be conducted on patients
or humans or animals?
Yes,
Investigations:
Diagnostic and evaluation:
Serum free testosterone.
LH: FSH Ratio.
Serum insulin.
Lipid profile.
Pelvic scan.
Exclusion:
Fasting blood sugar.
Serum Testosterone.
Thyroid Profile.
UPT.
CBP with ESR.
CUE.
Safety profile:
LFT- SGOT, SGPT, Alkaline Phosphatase.
RFT-Blood urea, Serum creatinine.
7.4
Has ethical clearance been obtained from your Institution in case of 7.3?
Yes
8.
List of references;
1. Zutshi V. Hormones in obstetrics and gynaecology. 2nd ed. New Delhi: Jaypee brothers;
2007: 11.
2. Fauci AS, Kasper D L. Harrison’s Principles of Internal Medicine. 7th ed. Vol I. USA:
Mc Graw Hill Medical; 2008: 300.
3. Desai P. Malhotra N. Principles and Practice of Gynaecology for Postgraduates. 3rd
edition, New Delhi: Jaypee Brothers Medical Publishers; 2008: 679.
4. Tyagi S, Singla M, Kumar S, Kumar A, Singh G, Narang N. Hirsutism- A symptom
rather than a disease: A review. International Journal of Pharma and Biosciences. Jul-Sep.
2010; 1(3):1-7.
5. Copeland L J. Textbook of Gynaecology. Philadelphia USA: W.B. Saunders Company;
1993: 427.
6. Sengupta BS, Chattopadhdhyay SK, Dutta DC. Gynaecology for Postgraduates &
practioners. 1st ed, New Delhi: Churchill Livingstone Pvt Ltd; 1998: 161.
7. Bieber E J, Sanfilippo J S, Horowitz IR. Clinical Gynaecology. 1st ed. Philadelphia:
Churchill Livingstone Elsevier; 2006: 893.
8. Khan A. Al Akseer. Vol II. (Urdu translation by Kabeeruddin). New Delhi: Ejaz
Publishing House; 2003: 1375, 1358, 1359, 1360.
9. Khan A.Qarabadeen Azam.(Urdu translation by Hasrat).New Delhi: Ejaz Publishing
House;1996:303.
10. Ibne Sina. Al Qanoon Fil Tib. Vol II.(Urdu translation by Kantoori G H) New Delhi:
Idara Kitabul Shifa; 1981: 343.
11. Razi A B Z. Al Hawi Fil Tib. Vol IX.(Urdu translation by CCRUM). New Delhi:
CCRUM; 2001: 153,154.
12. Ghani NH. Khazayanul Advia. New Delhi: Idara kitabulshifa; 1331,1333.
13. Yildiz BO, Bolour S, Woods K, Moore A, Azziz R. Visually Scoring Hirsutism.
Human Reproduction Update. June 30, 2009; 16(1). 51-64.
14. Ali BH, Blunden G, Tanira MO, Nemmar A. Some Phytochemical,Pharmacological
and Toxicological Properties of ginger (Zingiber officinale Roscoe): A review of recent
research. Food and Chemical Toxicology 46.2008;409-420.
9.
Signature of the candidate
10.
Remarks of the guide
11.
Name and Designation of
11.1
Guide
11.2
Signature
11.3
Co-guide
11.4
Signature
11.5
Head of the Department
11.6
Signature
12
Remarks of chairman and principal
12.2
Signature
National Institute Of Unani Medicine
Kottigapalya, Magadi Main Road, Bangalore-560091
Informed Consent Form
Title of the study: Clinical evaluation of efficacy of test drugs on Hirsutism in polycystic
ovarian disease.
Information to the participant:
Hirsutism is defined as excessive terminal hair on face or body in woman, and is a sensitive
marker for increased androgen production. Incidence of Hirsutism is 10%, and is present in
about 70% of patients of polycystic ovarian disease. Skin 5 alpha reductase activity largely
determines the presence and absence of hirsutism, which is influenced by racial
characteristics. In India it is found 10.5 % in Kashmir. Hyperandrogenism, infertility and
endometrial hyperplasia are common consequences of polycystic ovarian syndrome. Among
this hirsutism may be distressing for a woman and deserves at least a cursory evaluation. In
Unani system of medicine many drugs are available that can be used to treat hirsutism.
The main aim of the present study is to evaluate the efficacy of test drugs in the
patients of hirsutism. 40 Patients are randomly allocated in to two groups i.e. 20 in test group
and 20 in control group. In test group drugs will be given for 3 consecutive months, stop
during menstruation and compared with control group. Assessment will be done at interval
of 15 days. The study requires the necessary pre and post treatment laboratory investigations
including hormonal profile to fulfil the criteria of study and to evaluate any adverse drug
reaction on body.
The present test drug formulation may prevent the further growth of hair and
appearance of new hair follicles in patients of hirsutism in polycystic ovarian syndrome by
maintaining hormonal balance and reducing the obesity without any adverse drug reaction.
Undertaking by the investigator:
Your consent to participate in the above mentioned study by Farzana Anjum, P.G.Scholar,
Department of Ilmul Qabalat wa Amraze Niswan, NIUM, Bangalore is sought, you have the
right to refuse consent or withdraw the treatment during any part of the study without giving
any reason, the study does not put any financial burden on you. If you have any doubt about
the study, please feel free to clarify the same even during the study, you are free to contact
the investigator for clarification if you desire. All the information /data collected from you
will be kept confidential.
Patient consent form
I--------------------------------------------------------exercising my free power of
choice, hereby given my consent to be included as a subject in the clinical trial of the drug(s)
or technique for the treatment of --------------------------------------------------------, the disease I
am suffering from.
I have been informed to my satisfaction, by the attending physician regarding the
purpose of the clinical trial, the type of the treatment and follow up including the laboratory
investigations to monitor and safeguard my body function.
I am also aware of my right to opt out of the trial at any time during the course of
the trial without having to give the reasons for doing so.
-------------------------------Signature of the P.G. Scholar,
-----------------------------Signature of the patient.
Farzana Anjum,
NIUM, Bangalore-91,
Phone no. 9742107263.
Guide: Dr. Umraz Mubeen,
HOD, Department of Ilmul Qabalat wa Amraze Niswan.
NIUM, Bangalore-91.
Date: -----------
place: ------------