CTRI/2024/09/073227已完成2 期
Yoga along with Ayurvedic diet for the management of Polycystic Ovary Syndrome: Feasibility Randomised Comparative Study.
Vibhuti Samarth Rao1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility (recruitment, adherence, acceptability, adverse events, appropriateness of outcome measures and participants experiences)
研究概览
简要总结
The overall aim of this study is to examine the feasibility of the trial procedures and to investigate any changes in objective and subjective outcome measures when using combined Ayurvedic diet and yoga therapies against modern dietary and lifestyle suggestions in women with PCOS.
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
- •Women aged 18 to 35 years diagnosed with PCOS based on the Rotterdam Criteria in the past 1 year with a BMI of 23 to 29.9, not taking any pharmacological, nutritional, or herbal treatments for PCOS, and being able to read and understand basic English.
排除标准
- •Currently pregnant, less than 6 weeks postpartum, diagnosed with severe anaemia, unwilling or unable to provide consent & adhere to the protocol, unable to travel to study sites for data collection, known cases of liver, kidney, cancer, and cardiovascular conditions, following any special diets such as time-restricted fasting, ketogenic diet, and vegan diet, known cases of gluten or lactose intolerance or any food allergy, on medication for metabolic, psychological disorders and other endocrine disorders.
结局指标
主要结局
Feasibility (recruitment, adherence, acceptability, adverse events, appropriateness of outcome measures and participants experiences)
时间窗: During and at the end of the trial at 12 weeks
次要结局
- Anthropometric (Waist-to-hip ratio in cm, Weight in kg,(BMI, Percent body fat in %, Visceral fat area in cm2,)
研究者
Vibhuti Samarth Rao
Medical Research Centre- Kasturba Health Society,
研究点 (1)
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