A prospective open labelled, single arm, non-randomized, single centric, phase II clinical trial to evaluate the efficacy of Parangisakkai chooranam in the management of soothagavaayu(PCOD)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Regulation of hormonal profile
研究概览
简要总结
This study is A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON-RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRAIL TO DETERMINE THE EFFECTIVENESS OF PARANGISAKKAI CHOORANAM IN THE MANAGEMENT OF SOOTHAGAVAAYU (PCOD). The primary outcome will be regulation of menstrual cycle, regulation of hormonal profile and regulation of ovulation. The secondary outcome will be evaluating the diagnostic parameters, assessment of pharmacological and biochemical parameters of trial drug. In case of any adverse events (AE) noticed, it will be referred to pharmacovigilance department Of SCRI. Further management of patients will be given in OPD facility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Menstrual irregularities (Secondary amenorrhea) (Oligo amenorrhea) 2.Hyperandrogenism(clinical/Biochemical) 3.polycystic ovaries (unilateral/bilateral) 4.seeking treatment for PCOS induced infertility.
排除标准
- •1.Diabetes mellitus 2.Hypertension 3.pregnancy and lactation.
结局指标
主要结局
Regulation of hormonal profile
时间窗: 40 days
It is mainly assessed for minimum 3 menstrual cycles by
时间窗: 40 days
1.Regulation of menstrual cycle
时间窗: 40 days
2.Regulation of hormonal profile
时间窗: 40 days
3.Disappearance/reduction in the size or number of cyst.
时间窗: 40 days
次要结局
- To evaluate physicochemical, phytochemicals, biochemical analysis of clinical trial drug(To evaluate the safety profile for acute and subacute toxicity of the trial drug)
研究者
Dr R Priyadharshini
Government Siddha Medical College and hospital, Palayamkottai