A Randomized Controlled Trial Evaluating the Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol With or Without Metformin in Non-Diabetic Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
研究概览
简要总结
This study evaluates the efficacy of alpha-lipoic acid combined with myo-inositol, with or without metformin, in improving menstrual regularity and ovulation in non-diabetic women with polycystic ovary syndrome (PCOS). The study also assesses metabolic, hormonal, and clinical outcomes.
详细描述
This is a prospective randomized controlled parallel-group clinical trial evaluating the effects of alpha-lipoic acid combined with myo-inositol, with or without metformin, in women with polycystic ovary syndrome (PCOS).
A total of 180 patients will be randomized into three groups:
Myo-inositol with folic acid Myo-inositol + alpha-lipoic acid Myo-inositol + alpha-lipoic acid + metformin
The study duration is 6 months. Outcomes include menstrual regularity, ovulation rate, hormonal parameters, metabolic markers, and clinical signs of hyperandrogenism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 21 to 40 years
- •Diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria
- •Not currently pregnant or lactating
- •No hormonal therapy within the last 3 months
- •Willing and able to provide informed consent
排除标准
- •- History of diabetes mellitus, hypertension, or thyroid disorders
- •History of cardiovascular, renal, or hepatic disease
- •Use of hormonal contraceptives or insulin sensitizers within the last 3 months
- •Known hypersensitivity or allergy to study medications (myo-inositol, alpha-lipoic acid, or metformin)
- •Non-Egyptian ethnicity
研究者
Ahmed Abdelkader
Lecturer Assistant
Beni-Suef University