CTRI/2023/10/058811尚未招募2 期
Comparision of effect of tablet metformin with lifestyle modification and placebo with lifestyle modification on adolescent PCOS - A RANDOMOZED CONTROLLED TRIAL
Sri Manakula vinayagar medical college and hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年10月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To assess the effect of tablet metformin on biochemical parameters like lutenizing hormone, toral testosterone, lipid profile, HbA1C in adolescent PCOS.
研究概览
简要总结
For treatment of adolescent PCOS generally only lifestyle modification and in severe cases oral contraceptive pills are used currently. In this study if there is a significant improvement in physical and biochemical parameters such as improvement in menstrual cycle regularization, reduction in hyperandrogenism usage of tablet metformin can be considered as an alternate in treating adolescent PCOS since metformin is a relatively safer drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 19.00 Year(s)（—）
- 性别
- Female
入选标准
- •Irregular cycle, clinical hyperandrogenism, biochemical hyperandrogenism.
排除标准
- •Primary amenorrhea due to structural deformities, regular cycle, gastritis, gastric ulcer, liver disease, depression or bipolar disorder, contraindication to exercise.
结局指标
主要结局
To assess the effect of tablet metformin on biochemical parameters like lutenizing hormone, toral testosterone, lipid profile, HbA1C in adolescent PCOS.
时间窗: 3months
次要结局
- To compare the effect of tablet metformin and lifestyle modification versus placebo and lifestyle modification for 3months in regularising the menstural cycles, reducing hirsutism, acne and obesity in adolescent PCOS(3months)
研究者
研究点 (1)
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