PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. / Name of the Candidateand Address / LUBNA FATIMA
PG 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 Study and Subject / M.S (Unani)–Ilmul Qabalat wa Amraze Niswan
4. / Date of Admission to Course / 16-11-11
5. / Title of the Topic / Clinical Efficacy of Zarawand Hindi (Aristolochia indica Linn.) in Menopausal Transition
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7.2 / Brief resume of the intended work
Need for the Study
Two hundred years ago only 30% of women lived through a menopause; now more than 90% will. Thus, the menopausal transition and post menopause is very much a condition of the 20th and 21 centuries. The majority of women can therefore expect to live over a third of their lives in a menopausal state.1
The menopausal transition encompasses a period of dynamic changes in reproductive and non reproductive tissues.2 It may be viewed as a problematic period of menstrual, emotional and physiological changes.3 Women also experiences higher prevalence of somatic and psychological symptoms.4
The menopause and the years of life spent on the menopausal state bring with them issues related to both quality of life and disease prevention and management.5 Hence, it is an area of active clinical intervention and research investigation.6
The controversy surrounding the pros and cons of HRT (Hormone Replacement Therapy) has left menopausal women, health professionals and society in general, confused as to how best to deal with both the short and long-term sequelae of the menopause.1
In Unani system of medicine, there are many drugs which are in use to ameliorate the signs and symptoms related to menopausal transition. Hence, there is a need to conduct clinical trial to assess the efficacy and safety of zarawand hindi (Aristolochia indica Linn.) in menopausal transition, as it is having mudirre baul wa haiz, muhallil, and musakkin properties. Moreover, phytochemical analysis of the test drug has revealed the presence of phytosterols glycoside, flavonoid and saponins.7 It is also proven pharmacologically for antipyretic, antifertility, anti-inflammatory, antiestrogenic 7 and immunomodulator properties.8
Review of Literature
In Unani classical text, it is mentioned that the human life is basically divided into four age groups, which are considered to carry their particular mizaj. The age group of 35-60 years is known as sinne kahulat in which mizaj becomes barid and yabis. In this age, production of ratubate gariziya is decreased to such an extent that it is insufficient to maintain hararate gariziya and all the quwa (power) starts deteriorating.9 Ehtebase haiz (stoppage of menses) occurs in this age naturally due to change of mizaj towards coldness. Further, the production of dam (blood) is decreased from jigar, whatever little is produced, tends to be toward coldness.10 This leads to manifestations such as fatigue, general myalgia, arthralgia, backache, neck pain, headache, loss of appetite, weight gain, hirsutism, nervousness, anxiety, depression, insomnia etc. 10, 11
In conventional medicine, the stages of menopausal transition are variable in duration and may be distinguished principally by changes in menstrual cycle length and regularity. Menopausal transition has been divided into an early and late phase by Soules and other at the Stages of Reproductive Aging Workshop (STRAW) held in July, 2001.12 Early transition: changes in cycle length of ≥7 days either direction observed for at least two consecutive cycles or 60 days amenorrhoea. Late transition: 90 days to 11 months amenorrhea.13
Menopausal transition is known to play major role in the aetiology of symptoms such as hot flashes, night sweats, menstrual problems and vulvovaginal atrophy. Mood changes, sleep disturbances and sexual dysfunction are also commonly reported and may be attributable to the hormonal aberrations experienced during the transition.2 The menopausal transition may begins as early as fourth decade (late 30s) and may vary between 2 to 8 years in length.3
Various tools or instruments have been designed to measure and assess symptoms during the menopausal transition; among them is Menopause Rating Scale (MRS) which is designed to assess menopause specific health related quality of life (QOL) to measure the severity of age/menopause-related complaints by rating a profile of symptoms. The MRS is composed of 11 items and is divided into three subscales a) somatic: hot flushes, heart discomfort/palpitation, sleeping problems, muscle and joints problems; b) psychological: depressive mood, irritability, anxiety, physical and mental exhaustion; c) urogenital: sexual problems, bladder problems and dryness of vagina.4
In classical text, though menopausal transition is not mentioned as such but its clinical features can be correlated with complications occurring due to ehtebase haiz.
Zarawand hindi has long been in use as a Unani drug for different ailments such as ehtebase haiz (amenorrhoea), tanqiae rehm, ikhraje janeen (abortificient), dama (asthma), istrikhae asaab (neurodegenrative disorders), wajaul mafasil etc as its having properties like mudirre baul wa haiz (emmenagogue), muhallil, musakkin, munaffis, mushile balgham etc.14
Objectives of the Study
· To assess the efficacy and safety of zarawand hindi (Aristolocia indica Linn.) in Menopausal transition.
Material and Methods
Source of Data
Patient attending female OPD and IPD of National Institute of Unani Medicine Hospital, Bangalore.
Method of Collection of Data
History, physical examination and laboratory investigations
Selection of Patients
Inclusion Criteria
· Menopausal transition women aged 35 or more
· Presence of any of these symptoms: menstrual changes, hypomenorrhoea, hot flushes, night sweats, sleep disturbances, palpitation, arthralgia, fatigue, anxiety, depression, urinary and sexual problems
· Women with early and late transition: Early transition: changes in cycle length of ≥7 days either direction observed for at least two consecutive cycles or 60 days amenorrhoea. Late transition: 90 days to 11 months amenorrhoea.
Exclusion Criteria
· Women with known systemic and endocrine diseases like uncontrolled hypertension and diabetes mellitus, thyroid dysfunctions or any psychiatric disorders, CAD, focal neurologic deficit, active thrombo-embolism, gastrointestinal ulcer and stroke.
· Women with undiagnosed vaginal bleeding, history of surgical menopause.
· Women with hypersensitivity to drugs and past history of taken HRT within two months
· Pregnant and lactating women
· Patients with any kind of malignancies
Study Design: Single-blind randomized placebo controlled study
Duration of Study: One and a half year
Sample Size: Total 45 patients
· 30 patients in test group
· 15 patients in control group
Treatment
Test Group: Test Drug
Orally:
Root of zarawand hindi (Aristolochia indica).
Method of Preparation, Route of Administration and Dosage:
The drug will be pounded, sieved and mixed well to make a homogenous powder. 4 g powder filled in capsules will be given orally in two divided doses daily.
Control Group
Placebo: Placebo will be given in same quantity as that of the test drug.
Duration of Treatment: 2 months
Procedure of study:
Diagnosed cases of menopausal transition after enrollment, they will be randomly allocated either to test (n=30) or control group (n=15) and written informed consent will be obtained. Orally, test group will be administered zarawand hindi 4 g in two divided doses, orally and placebo will be given same as that of the test drug for duration of 2 months. In placebo group, patients will be clinically assessed once every fortnightly, if any symptoms gets markedly aggravated then such patients will be excluded from the study and will be given standard treatment.
Follow up
· During treatment : Once every fortnightly
· After treatment : Once after one month
Withdrawal Criteria
· Failure to follow the protocol
· The cases in which drug adverse reactions will be noticed
Informed Consent
Patients fulfilling the inclusion criteria mentioned above will be shown information sheet having details regarding the nature of study, and 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.
Parameter of Efficacy
Assessment of Efficacy
The efficacy of the test drug will be assessed by Menopausal Rating Scale (MRS). 4
Main Outcome Measure: Reduction in MRS scores.
Assessment of Safety
Physical examination and by laboratory investigations.
Adverse Effects Documentations
Any adverse reaction of drugs will be documented.
Documentation
The record will be submitted to the department after completion of study.
Statistical Analysis
The appropriate tests will be applied to analyse the data. The descriptive statistical analysis will be used in the present study. Results on continuous measurements will be presented in mean (SD/SEM) and results on the categorical measurements will be presented in number (%) with 5% level of significance and 95% confidence interval.
7.3 / Does the study require any investigations or interventions to be conducted on patients or other humans or animals? / Yes
Investigations:
Pre test :
Haematological: CBP, ESR, RBS, SGOT, SGPT, alkaline phosphatase, blood urea, serum creatinine
Urine: Complete urine analysis
Thyroid Profile
USG (Abdomen)
Vaginal cytology (for maturation index)
Post-test:
Hb, ESR, SGOT, SGPT, alkaline phosphatase, blood urea, serum creatinine
Vaginal cytology (for maturation index)
7.4 / Has ethical clearance been obtained from your Institution in case of 7.3 / Approved
8. / References:
1. Edmonds D.K. Dewhurst’s textbook of Obstetrics and Gynaecology. 7th edition. USA: Blackwell Publishing:2007.p.479-493.
2. Sherman S. Defining the menopausal transition. American Journal of Medicine 2005; 118(12B):3S-7S.
3. Brown C, Ling FW. Perimenopause. In Bieber EJ, Sanfilippo JS, Horowitz IR, the editor Clinical Gynaecology. Canada:Churchill Living Stone;2006.p.875-892.
4. Rahman SASA, Zainudun SR, Mun VLK. Assessment of menopauseal symptoms using modified Menopause Rating Scale (MRS) among middle age women in Kuching, Sarawak, Malaysia. Asia Pacific Family Medicine 2010;9:5.
5. Lund K. J. Menopause and the Menopausal Transition. The Medical Clinics of North America 2008:1253-1271.
6. Santoro N. The menopause transition: an update: Human Reproduction update: 2007;8(2):155-160.
7. Dey A, De JN. Aristolochia indica: A Review. Asian Journal of Plant Sciences 2011: 10: 108-116.
8. Indian birthwort. URL: http://medical-dictionary.thefreedictionary.com/Indian+birthwort [Accessed on 13-3-12].
9. Ahmed S.I. Kulliyate Asri. Delhi: New Public Press;1983.p.63.
10. Jurjani AH. Tarjumae Zakheera Khawzam Shahi (Trans: Khan HH). New Delhi: Idara Kitabus Shifa 2010.p.599-600.
11. Razi ABZ. Kitabul Hawi. Vol. 9. CCRUM: New Delhi;2001.p.151-158.
12. Schorge JO, Schaffer JI, Halvorson L M, Bradshaw K D, Cunningham FG. Williams Gynecology. USA: McGraw Hill Publishers; 2008.p.468-490.
13. Sammel MD, Freeman EW, Liu Z, Lin H, Guo W. Factors that Influence Entry into Stages of the Menopausal Transition. Menopause. 2009 Nov–Dec; 16(6): 1218–1227. doi: 10.1097/gme.0b013e3181a8f62b [Accessed on 8-3-12].
14. Anonymous. The Unani Pharmacopeia of India. Part. I, Vol. V. New Delhi; Department of AYUSH, 2008.p.109-110.
9. / Signature of Candidate
A / Remarks of Guide / Recommended for approval
11 / Name & Designation of
11.1 / Guide / Arshiya Sultana,
Lecturer, Dept of Ilmul Qabalat wa Amraze Niswan
National Institute of Unani Medicine,
Kottigepalya, Magadi Main Road, Bangalore
Karnataka-560091
11.2 / Signature
11.3 / Co- Guide / Not applicable
11.4 / Signature / Not applicable
11.5 / Head of Department / Prof. M A Siddiqui
In-charge HoD
Dept of Ilmul Qabalat wa Amraze Niswan
NIUM Bangalore
11.6 / Signature
12 / Remarks of Director
12.1
12.2 / Signature
NATIONAL INSTITUTE OF UNANI MEDICINE
Kottigeplaya, Magadi Main Road, Bangalore-91
INFORMATION SHEET
Title of the study:
Clinical Efficacy of a Unani drug in Menopausal Transition
Information to the patients
The menopausal transition may begin as early as fourth decade (late 30s). In this disease women may present with symptoms such as hot flashes, night sweats, menstrual problems and vulvovaginal atrophy, mood changes, sleep disturbances and sexual dysfunction. These symptoms affect women’s quality of life, hence needs treatment. There is conservative management in conventional medicine, with many limitations and side effects. The test drugs have been used for long time and mentioned already in the Unani literature to be safe and effective.
The present study is to validate the efficacy and safety of the test drug. Total subjects of the study will be divided randomly into two group i.e., 30 patients in the test group and 15 patients in the control group. The test group will be treated with Unani drug for 8 weeks and compared with the control group. Pretest and post test laboratory investigations involving blood sample and urine analysis will be done to fulfill the criteria of the study and to evaluate any adverse drug reactions on body functions. It is expected that there will be relief in symptoms of menopausal transition with the test drug without any adverse drug reactions.
Undertaking by the research scholar
All the information/data about you and your problem will be kept in strict confidence. Your consent to the above mentioned study by Lubna Fatima P.G scholar, Dept of Ilmul Qabalat wa Amraze Niswan, NIUM, Bangalore is sought. You have the right to continue, refuse consent or withdraw the same during any part of the study without any reason. The study does not put any financial burden on you. If you have any doubts about the study, please feel free to clarify the same. Even during the study, you are free to contact the research scholar for clarification if you desire so.
CONSENT FORM
I ------exercising my free power of choice, hereby give my consent to be included as a subject in the clinical trial of the drug(s) 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 and the nature of the drug 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
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Signature of the P G Scholar Signature of the patient
Dr. Lubna Fatima.
Dept. of Ilmul Qabalat wa Amraze Niswan,
Contact No: 07676860426
Guide: Dr. Arshiya Sultana
Lecturer,
Dept. of Ilmul Qabalat wa Amraze Niswan, NIUM Bangalore-91
Contact No: 09740915911
Date:
Place: Bangalore
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