| CTRI Number |
CTRI/2015/06/005868 [Registered on: 04/06/2015] Trial Registered Retrospectively |
| Last Modified On: |
08/09/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of a Unani drug in menopasual transition |
|
Scientific Title of Study
|
Clinical Efficacy of Khare khask (Tribulus terresteris)in Menopausal transition. |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lubna Fatima |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepalya, Magadi Main, Bangalore
Dr Arshiya Sultana, Lecturer, Dept of Amraze Niswan,
National Institute of Unani Medicine, Kottigepalya
Bangalore
KARNATAKA
560091
India |
| Phone |
7676860426 |
| Fax |
|
| Email |
drfatima35@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arshiya Sultana |
| Designation |
Lecturer, Dept. of Amraze Niswan |
| Affiliation |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore
002, 6&7 Ranganatha Regency, 12th cross, 2nd MN, Annapoorneshwari Nagar
Bangalore, Karnataka
Bangalore
KARNATAKA
560091
India |
| Phone |
9740915911 |
| Fax |
|
| Email |
drarshiya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Arshiya Sultana |
| Designation |
Lecturer, Dept. of Amraze Niswan |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dr Arshiya Sultana, Lecturer, Dept of Amraze Niswan,
National Institute of Unani Medicine, Kottigepalya
002, 6&7 Ranganatha Regency, 12th cross, 2nd MN, Annapoorneshwari Nagar
Bangalore, Karnataka
Bangalore
KARNATAKA
560091
India |
| Phone |
9740915911 |
| Fax |
|
| Email |
drarshiya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National institute of Unani medicine, Under Ministry of health and family welfare, Govt. of India |
|
|
Primary Sponsor
|
| Name |
National Institute of unani Medicine |
| Address |
Kottigepalya, Magadi Main Road,
Bangalore, Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Lubna Fatima |
National Institute of Unani Medicine |
Room No.29, Dept. of Amraze Niswan (Gyne and Obst) Kottigepalya, Magadi Main Road
Bangalore
KARNATAKA |
7676860426
drarshiya@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Menopausal transition symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Khare khask (Tribulus terretris |
The drug will be pounded, sieved and mixed well to make a homogenous powder. 6g powder filled in capsules will be given orally in two divided doses daily
Duration of treatment was for eight weeks. |
| Comparator Agent |
Micro-Crystalline cellulose |
Placebo powder will filled int capsules, 6 g will be given orally in two divided doses daily for eight weeks. Duration of treatment will for eight weeks. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
• 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.
|
|
| ExclusionCriteria |
| Details |
•Women with known systemic and endocrine diseases like uncontrolled hypertension and diabetes mellitus, thyroid dysfunctions.
•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
•Women with any kind of malignancies
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The efficacy and safety of the test drug will be assessed by Menopausal Rating Scale (MRS). |
three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in menstrual irregularities (amenorrhoea, oligomenorrhoea and hypomenorrhoea) |
three months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/04/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Two hundred years ago only 30% of women lived through a menopause; now more than 90% will. Thus, the menopause 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. In Unani system of medicine, there are many drugs which are in use to relieve the sign and symptoms related to menopausal transition. Hence, there is a need to conduct clinical trial to assess the efficacy and safety of Khare khask (Tribulus terrestris Linn.) in menopausal transition, as its having mudirre baul wa haiz, muhallil auram and muqawwie bah. Moreover, the test drug has pharmacological activity such as analgesic, antihistamine, anti-inflammatory, antispasmodic, aphrodisiac, CNS depressant, diuretic and estrogenic effect. 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. The menopausal transition may begins as early as fourth decade (late 30s) and may vary between 2 to 8 yrs in length. 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 was 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. The objective of the study is to assess the efficacy and safety of Khare khask (Tribulus terrestris Linn.) in Menopausal transition. This is a prospective, single-blind, placebo controlled trial on 60 patients divided into two equal groups. The symptoms will be evaluated by MRS score.
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