Evaluation of Comparative Efficacy of Chandrashoor Churna versus Tablet Metformin with dietary and lifestyle modifications in both groups in the Management of Artavakshaya (Oligomenorrhoea in Polycystic Ovarian Syndrome): A Randomised Control Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Chandrashoor Churna with dietary and lifestyle regimen in the Management of Artavakshaya (Oligomenorrhoea in polycystic ovarian syndrome)
研究概览
简要总结
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per a computer-generated table. The clinical research format will be prepared and validated. Before the study approval is taken from lEC, MGACHRC, Salod (H) Wardha, and CTRI registration will be done.
After selection, each participant will be tested individually and selected according to the selection criteria. They are divided into two groups. The trial is a Randomized Control Clinical Trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females aged 18 35 years Diagnosed with PCOS based on USG Presenting with symptoms of Oligomenorrhoea Presenting with symptoms of Artavakshaya Scanty menstrual flow Informed consent given.
排除标准
- •Women with secondary causes of amenorrhea eg hypothyroidism hyperprolactinemia premature ovarian failure Presence of structural abnormalities eg fibroids endometriosis or tubal blockagesKnown cases of Type 1 or Type 2 diabetes mellitus Thyroiddysfunction Hyperprolactinemia Cushings syndrome Women on Hormonal therapy OCPs HRT etc Antidiabetic antiobesity or steroidal drugs in the past 3 months Lactating women or who want to conceive during this period Known allergy or intolerance to Chandrashoor or Metformin History of chronic illnesses affecting reproductive health (e.g renal failure, liver disease) Participation in any other clinical trial within the last 3 months.
结局指标
主要结局
To assess the efficacy of Chandrashoor Churna with dietary and lifestyle regimen in the Management of Artavakshaya (Oligomenorrhoea in polycystic ovarian syndrome)
时间窗: 0 week,4 week, 8 week
次要结局
- To evaluate and compare the improvement in menstrual irregularities, reduction in pain in both groups.(3 months (2 consecutive menstrual cycle ) during study With 3 months (2 consecutive menstrual cycle ) follow up after study)
研究者
Dr Disha Sudhakar Shetty
Mahatma Gandhi Ayurveda College Hospital and Research Centre ,Salod Wardha