A comparative clinical study on the effect of Vamana karma and Bhadradi kaphanashaka kala basti and Shatapushpadi ghanawati in the management of Aartava kshaya wsr Polycystic ovarian syndrome (PCOS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- regulation of normal menstrual pattern and assesment of disease condition including factors like obesity hirsutism etc
研究概览
简要总结
This study is a randomised open labelled parallel group comparing effect of Vamana karma (therapeutic emesis) and Basti karma (medicated enema) followed by Shatapushpadi Ghanawati in both the groups for 45 days in 30 patients (15 patients in each group) of polycystic ovarian syndrome is conducting in National Institute of Ayurveda in India.
Vamana karma is a shodhana therapy in whichSnehapana with Murchita tila taila followed by Vamana procedure by Ikshwaku beeja choorna yoga given as per standard Panchakarma protocol according to patient`s Agni and Koshtha stithi till Samyaka shudhi lakshana will be acheived.
Basti karma with Bhadradi kaphanashaka basti inKala basti schedule ( 16days) ,initially 2 Aanuvasana basti with Sarshapa oil followed by alternateAanuvasana(Medicated oil enema) and Niruha(decoction enema) combination followed by Aanuwasana basti (medicated oil enema) at the end.
The primary outcome measures are regulation of normal menstrual pattern and assesment of disease condition including factors like obesity, hirsutism etc after 60 days of treatment. The secondary outcome is regulation of normal menstrual pattern and assesment of PCOS related complications at 15 days and 60 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Age group 20 to 40 yrs both unmarried and married patients 2 PCOS diagnosed cases by revised rotterdam criteria 3 Irregular menses scanty menses due to anovulatory cycle 4 Patient fit for Vamana and Bastikarma.
排除标准
- •1 Cervical tumor polyp Ca cervix 2 Uterine fibroid 3 Congenital anomalies in female genital tract 4 Tubercular endometritis 5 Congenital adrenal hyperplasia 6 HIV VDRL HbsAg positive 7 Malignant disease and patients on cytotoxic drugs 8 Patient not fit for Vamana and Bastikarma.
结局指标
主要结局
regulation of normal menstrual pattern and assesment of disease condition including factors like obesity hirsutism etc
时间窗: 60 DAYS
次要结局
- regulation of normal menstrual pattern and assesment of PCOS related complications.(15 DAYS 60 DAYS)