In vitro and controlled clinical study of shatapushpa churna in polycystic ovarian syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- -To observe the histopathological changes & steroidogenic enzyme activity in ovary in the Laterozole induced PCOS rat animal after administration of Shatapushpa churna
研究概览
简要总结
Title of the study is IN VITRO & CONTROLLED CLINICAL STUDY OF SHATAPUSHPA CHURNA IN POLYCYSTIC OVARIAN SYNDROME. This study is animal experimental study & open randomised controlled clinical study. Animal study will be done at NIRRH ICMR Parel,Mumbai & will be performed on total 48 rats (6 groups having 8 rats each).
Selection of PCOS cases and confirmation of exclusion and inclusion criteria is done with proper investigations required done.
Shatapushpa dry seeds are purchased from the available source in market.Its fine powder is prepared as per the standard norms mentioned in Ayurvedic Text.10gm of churna is administered orally early morning empty stomach with Goghrut to each subject with PCOS.Standardisation and authentification of the drug is done from ALARSIN Pharmaceuticals,Mumbai.Tablet Metformin sustained release 850mg is given to the subjects in control group.Total 100 sample size is taken for the study.
Data collection and results will be recorded.
Statistical calculations will be done as per the suitable guidelines.Conclusion will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •All married & unmarried cases -USG with polycystic ovaries showing multiple small peripheral follicles(>12 follicles)in each ovary measuring 2-9mm in diameter and/or increased ovarian volume >10mm.
- •All cases of PCOS having amenorrhoea/oligomenorrhoea.
- •PCOS patients having signs of hyperandrogenism.
排除标准
- •Amenorrhoea of menopause -Patients of PCOS with DM/HTN/Hypothyroidism/Hyperthyroidism/TB/HIV/HbSAg/VDRL -Cases of prgnancy,cervical tumor/polyp, uterine fibroid -known cases of systemic illness like asthma,cardiovascular and renal diseases,malignancy, Salpingo oophoritis, Cervical erosion, anatomical defective genitalia.
结局指标
主要结局
-To observe the histopathological changes & steroidogenic enzyme activity in ovary in the Laterozole induced PCOS rat animal after administration of Shatapushpa churna
时间窗: 9 MONTHS
-To evaluate the ovulatory effects of Shatapushpa churna in Latrazole induced PCOS in rat animal
时间窗: 9 MONTHS
-To study the clinical action of Shatapushpa Churna in PCOS by assessing ovulatory effects ,reduction in ovarion volume and status of menstruation.
时间窗: 9 MONTHS
次要结局
- -To evaluate the effects of Shatapushpa churna in PCOS by assessing the changes in biochemical markers like FSH LH E2 TESTOSTERON DHEAS GTT SERUM LIPID PROFILE SERUM INSULIN LEVEL(-To assess the effect of Shatapushpa churna in Achanthosis Nigrans Hirsutism Acne)