Effect of add-on therapy alpha lipoic acid on insulin resistance in high body mass index polycystic ovary syndrome patients -A randomized , double -blinded , placebo-controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Improvement in Insulin sensitivity by estimating HOMA-IR from baseline to 12 weeks in overweight &obese PCOS patients
研究概览
简要总结
This MD thesis proposal aims to assess the impact of alpha lipoic acid supplementation on insulin resistance in Overweight and obese PCOS patients. The study, with a sample size of 84, will evaluate insulin resistance markers, NAFLD indexes. Participants will be randomized into probiotic and placebo groups, receiving treatment for 12 weeks, with regular follow-ups to monitor compliance and adverse effects. The study outcomes may contribute valuable insights to the limited body of randomized controlled trials on the alpha lipoic acid in PCOS patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients whose bmi is above 23kg/m2 who is diagnosed with PCOS 7 taking metformin for a period 3 months.
排除标准
- •Breastfeeding, Lactation mothers Females affected by renal disease, liver disease, cardiac disease H/o pt taking alcohol Pcos pts who is on hormonal treatment.
结局指标
主要结局
Improvement in Insulin sensitivity by estimating HOMA-IR from baseline to 12 weeks in overweight &obese PCOS patients
时间窗: Improvement in Insulin sensitivity by estimating HOMA-IR from baseline to 12 weeks in overweight &obese PCOS patients
次要结局
- Improvement in liver index scores by measuring lipid accumulation product hepatic steatosis index from baseline to 12 weeks(12 weeks)
研究者
vijayalakshmi
SRM medical college hospital research instiute