Clinical Efficacy of Satavar (Asparagus racemosus) in Post-Menopausal Syndrome (Mutlazima Sinne Yaas) - A randomized placebo control single blind study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- RELIEF IN HOT FLASHES AND OTHER ASSOCIATED SYMPTOMS OF POST MENOPAUSAL SYNDROME
研究概览
简要总结
CLIMACTERIC IS THE PHASE OF WANING OVARIAN ACTIVITY AND MAY BEGIN 2-3 YEARS BEFORE MENOPAUSE AND CONTINUE FOR 2-5 YEARS AFTER IT. THUS, THE CLIMACTERIC IS THE PHASE OF ADJUSTMENT BETWEEN ACTIVE AND INACTIVE OVARIAN FUNCTION AND IT INVOLVES PHYSICAL, SEXUAL AND PSYCHOLOGICAL ADJUSTMENTS.
MENOPAUSAL SYMPTOMS INCLUDE HOT FLASHES CHARACTERIZED BY SUDDEN FEELING OF HEAT FOLLOWED BY PROFUSE SWEATING WHICH IS THE DOMINANT AND CLASSICAL SYMPTOM. OTHER SYMPTOMS ARE INCONTINENCE, URGENCY OF URINE, VAGINAL DRYNESS, PAINFUL INTERCOURSE, DECREASE LIBIDO, SKIN DRYNESS AND WRINKLING, JOINT STIFFNESS & SORENESS, OSTEOPOROSIS. PSYCHOLOGICAL SYMPTOMS INCLUDE DEPRESSION, HEADACHE, INSOMNIA, ANXIETY, MENTAL CONFUSION, IRRITABILITY, CAN ALSO OCCUR IN POST-MENOPAUSAL WOMEN. IN ADDITION TO THESE, FEMALES ARE AT HIGH RISK OF DEVELOPING ISCHEMIC HEART DISEASES, CORONARY ARTERY DISEASES, BREAST CANCER, OSTEOPOROSIS AND FRACTURE IN FUTURE.
IT IS A MAJOR PROBLEM OF ELDERLY WOMEN POSSESSING BOTH PSYCHIC & SOMATIC SYMPTOMS, WHICH CREATE TROUBLES IN DAILY BEHAVIOR & MAINTAINING THE HEALTHY LIFE. NUMBER OF MENOPAUSAL WOMEN IN INDIA IS 43 MILLION. IT IS PREDICTED THAT THE TOTAL NUMBER OF POST- MENOPAUSAL WOMEN IN 2030 WILL BE APPROXIMATELY 1200 MILLION & THE PROPORTION OF THOSE LIVING IN THE DEVELOPING COUNTRIES WILL BE NEARLY 76% .
FOLLOWING MENOPAUSE THERE IS A SHARP FALL IN ESTROGEN (66%) AND ANDROGEN (50%) CAUSING REBOUND INCREASE IN FOLLICLE STIMULATING HORMONE AND LUTEINIZING HORMONE, HENCE THERE IS DISTURBANCES IN THE PHYSIOLOGICAL AND METABOLIC FUNCTIONS OF BODY.
UNANI SYSTEM OF MEDICINE IS ENRICHED WITH THE CONCEPT OFEHTIBAS-E-HAIZ (AMENORRHOEA) BUT THERE IS NO EXACT DESCRIPTION OF MENOPAUSE, NEVERTHELESS IT MAY REVEALED UNDER EHTIBAS-E-TAMS AND CAN BE CORRELATED WITH SIN-E-YAAS(AGE OF NATURAL TERMINATION OF MENSTRUATION).
ESTROGEN LEVEL FALLS OVER THE 5 YEARS PRECEDING OVARIAN FAILURE, WHICH OCCURS USUALLY BETWEEN 45 AND 55 YEARS OF AGE, WITH AN AVERAGE OF AROUND 50 YEARS. THE ABOVE MENTIONED AGE GROUP IN UNANI LITERATURE IS DESCRIBED AS SIN-E-K**AHOOLATWHICH STARTS AT AROUND 35-40 YEARS OF AGE AND LASTS ABOUT 60 YEARS OF AGE. ACCORDING TO ZAKARIA RAZI, PHYSIOLOGICAL AMENORRHEA MAY TAKE PLACE BETWEEN 40 TO 60 YEARS OF AGE. HE FURTHER MENTIONED IN HIS BOOK THAT SUCH CONDITION COMES INTO EXISTENCE DUE TO SU-E-MIZAJ B**ARID(COLD TEMPERAMENT) OR KHILT-E-BARID(COLD HUMOUR).
RECENT SCIENTIFIC STUDIES REVEALED THAT MANY SINGLE HERBAL DRUGS LIKE ASGANDH (Withania somnifera) AND TUKHM E KATAN (Linum usitatissimum*)* CONTAIN PHYTOESTROGENS WHICH HAS SHOWN THE GOOD RESULTS BY DECREASING THE SYMPTOMS OF POST-MENOPAUSAL SYNDROME.
A UNANI DRUG SATAVAR (Asparagus racemosus) IS SELECTED FOR STUDY IN PATIENTS OF POST MENOPAUSAL SYNDROME WHICH CONTAINS PHYTOESTROGENIC PROPERTIES ALONG WITH MUQAWWI-E-QALB(CARDIAC TONIC), MUHALLIL-E-WARM (ANTI-INFLAMMATORY), EMOLLIENT, COOLING, NERVINE TONIC, ANTI-DEPRESSANT, DIURETIC, REJUVENATING, CARMINATIVE, STOMACHIC, ANTISPASMODIC, ANTISEPTIC, ANTIOXIDANT AND HEPATOPROTECTIVE ACTIVITY.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- Female
入选标准
- •PATIENTS WITH HISTORY OF AMENORRHOEA FOR 1 YEAR ASSOCIATED WITH HOT FLASHES ALONG WITH MORE THAN OR EQUAL TO 3 SYMPTOMS THAT ARE MENTIONED IN THE GREENE CLIMACTERIC SCALE.
排除标准
- •PATIENT HAVING AMENORRHEA DUE TO OTHER PATHOLOGY,OR SUFFERING FROM HTN, TB, CANCER, DM, THYROID DISORDER, STI, LIVER AND KIDNEY DISEASE, ESTABLISHED CASES OF ANY MAJOR PSYCHIATRIC DISORDER SUCH AS SCHIZOPHRENIA AND MENTAL RETARDATION, PATIENT ON HORMONE REPLACEMENT THERAPY WITHIN 60 DAYS OF STUDY PERIOD OR POST-MENOPAUSAL BLEEDING.
结局指标
主要结局
RELIEF IN HOT FLASHES AND OTHER ASSOCIATED SYMPTOMS OF POST MENOPAUSAL SYNDROME
时间窗: SYMPTOMS WILL BE ASSESSED AT THE INITIATION OF THE STUDY AND MONTHLY FOR 3 MONTHS
次要结局
- IMPROVEMENT IN GREENE CLIMACTERIC SCALE(IMPROVEMENT IN QUALITY OF LIFE (QOL) QUESTIONNAIRE)
研究者
SUMAIYYA KHANAM
ALIGARH MUSLIM UNIVERSITY
