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临床试验/CTRI/2024/08/071979
CTRI/2024/08/071979尚未招募3 期

A Comparative Clinical Study to evaluate the efficacy of Sapthavimshathi Guggulu and Soubhagya Vati after Virechana in Perimenopausal syndrome

Dr Hasinabegum P1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Assessing relief in the symptoms of Perimenopausal syndrome like hot flushes,sweating,sleep problems,muscle and joint pain.

研究概览

简要总结

Menopause means permanent cessation of menstruation at the end of reproductive life due to loss of ovarian follicular activity. Perimenopause is the part of the climacteric where the menstrual cycle is likely to be irregular  It is associated with erratic fluctuation in reproductive hormone levels often leading to vasomotor symptoms change in mood or cognition and sexual dysfunction The prevalence of peri menopausal syndrome is 1.79% in 40 to 45 years 7.98% in 45-50 years In Ayurveda the time of Rajonivrutti is said to be 50 years  The stage of Parihani (from 41 to 70 years) which comes under classification of age according to Sushrutha can be considered as perimenopausal age During this phase Sapthadhatu starts to debilitate This is the stepping stage from Madhyama Avastha to Vruddha Avastha  This phase is the transition from Pitta Pradhana Avastha to the Vata Pradhana Avastha Both Shareerika and Maanasika doshas are affected producing symptoms like Alasya Shrama Dourbalya (physical exhaustion)  Nidranasha (sleep problems)  Klama The hormone replacement therapy is indicated in the menopausal women to overcome the short term and long term consequences of estrogen deficiency  But estrogen hormone in long term usage causes endometrial and breast cancer coronary heart disease  venous thromboembolic disease  dementia and Alzheimer disease So non hormonal way of approach through ayurveda can be a priority  Hence the study to evaluate the effect of Saptavimshati Guggulu and Soubhagya Vati after Virechana to manage both Shareerika and Manasika doshic vitiation in perimenopausal syndrome will be undertaken

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Female subjects of age group 40 to 50 years Subjects diagnosed based on diagnostic criteria.

排除标准

  • Subjects who have attained surgical menopause will be excluded Subjects who are having uncontrolled diabetes and hypertension will be excluded Subjects who are suffering from any other systemic disorders which interfere with the course of disease and treatment will be excluded Subjects who are unfit for Virechana will be excluded.

结局指标

主要结局

Assessing relief in the symptoms of Perimenopausal syndrome like hot flushes,sweating,sleep problems,muscle and joint pain.

时间窗: at baseline, after samsarjana krama(mid assessment) and 28th day after samsarjana krama(post assessment)

次要结局

  • To compare the efficacy of Sapthavimshathi Guggulu and Soubhagya Vati after Virechana in Perimenopausal syndrome by assessing relieving of symptoms through Green Climacteric Scale(40th day)
  • To compare the efficacy of Sapthavimshathi Guggulu and Soubhagya Vati after Virechana in Perimenopausal syndrome by assessing relieving of symptoms through Green Climacteric Scale(After Virechna)

研究者

发起方
Dr Hasinabegum P
申办方类型
Other [[self]]
责任方
Principal Investigator
主要研究者

Dr Hasinabegum P

Government Ayurveda Medical College and Hospital Mysore

研究点 (1)

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