Effect of a Unani drug in menopasual transition
- Conditions
- Menopausal transition symptoms
- Registration Number
- CTRI/2015/06/005868
- Lead Sponsor
- National Institute of unani Medicine
- Brief Summary
Twohundred 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 60
- •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.
- •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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The efficacy and safety of the test drug will be assessed by Menopausal Rating Scale (MRS). three months
- Secondary Outcome Measures
Name Time Method Improvement in menstrual irregularities (amenorrhoea, oligomenorrhoea and hypomenorrhoea) three months
Trial Locations
- Locations (1)
National Institute of Unani Medicine
🇮🇳Bangalore, KARNATAKA, India
National Institute of Unani Medicine🇮🇳Bangalore, KARNATAKA, IndiaLubna FatimaPrincipal investigator7676860426drarshiya@yahoo.com