CTRI/2024/04/065564尚未招募3 期
Effectiveness of non hormonal treatment for the management of obese PCOS patients compared to the standard treatment.
PGIMER post graduate institute of medical education and research1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年3月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- percentage reduction in body weight
研究概览
简要总结
this trial is aimed for treating PCOS patients targeting the pathophysiology of disease and not just providing symptomatic treatment.here we have taken 3 arms of intervention. arm1 is intensive lifestyle modification along with metformin and anti androgens. arm 2 is semaglutide , metformin and anti androgens and arm 3 is oral contraceptive pills with spironolactone. we will be assessing reduction in body weight and free androgen index reduction as primary objectives.
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 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •3 arms are there for PCOS treatment.
- •arm 1 being given drugs with lifestyle modification , arm 2 being given only drugs and arm 3 being given standard treatment with OCPs.
排除标准
- •age less than 18 years and more than 40 years female type 2 DM malignancy acute infection chronic infection pregnant.
结局指标
主要结局
percentage reduction in body weight
时间窗: at 12 months
free androgen index
时间窗: at 12 months
次要结局
- menstrual irregularities(hirsutism)
研究者
Dr Rama Walia
PGIMER ( post graduate institute of medical education and research )
研究点 (1)
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