A prospective randomised comparative study of metformin versus myoinositol plus d-chiroinositol combination therapy in polycystic ovarian syndrome
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate the changes in the hormone levels of LH, FSH, AMH, testosterone, insulin, progesterone, estrogen and regularity of menstrual cycle after giving the interventional treatment.
研究概览
简要总结
Polycystic ovarian syndrome is one of the most common endocrine disorders in women of reproductive age. The Rotterdam Criteria is to be fulfilled to diagnose the syndrome which requires the presence of two out of three conditions: Oligomenorrhea and/or anovulation, clinical and/or biochemical signs of hyperandrogenism that may be associated with hirsutism, and ultrasound findings showing polycystic ovaries. Hyperandrogenism is the cornerstone of the syndrome. Insulin resistance and resultant hyperinsulinaemia contribute to hyperandrogenism in these patients. Weight loss or pharmacologic interventions that lower insulin levels have shown to significantly reduce androgen levels and improve menstrual cycle patterns in many of these women. This study is planned specifically to evaluate the efficacy of metformin versus myoinositol plus d-chiroinositol combination therapy in PCOS patients and its subsequent effects on their clinical, hormonal and radiodiagnostic dimensions. The present study will be prospective, randomized parallel design interventional study for the duration of nine months. 50 newly diagnosed PCOS patients from the department of Obstetrics & Gynaecology, Government Medical College, Amritsar will be randomly divided into 2 groups, one group will be given Metformin 500 mg BD & other group Myoinositol plus d-chiroinositol combination therapy 1000 mg BD daily for 9 months. Follow up will be done at 3,6,9 months. At each visit, LH, FSH, AMH, testosterone, insulin, progesterone, estrogen and ultrasonic evidences will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 15.00 Year(s) 至 49.00 Year(s)(—)
- 性别
- Female
入选标准
- •Women fulfilling 2 out of 3 criteria of Rotterdam criteria Oligo menorrhea and/or Anovulation Clinical and/or hormonal parameters of hyperandrogenism that may be associated with Hirsutism Polycystic ovaries in ultrasound findings.
排除标准
- •Women with pre-existing endocrine disorder History of Hypertension & Diabetes Mellitus Women who received previous treatment with other drugs within last 6 months Pregnancy.
结局指标
主要结局
To evaluate the changes in the hormone levels of LH, FSH, AMH, testosterone, insulin, progesterone, estrogen and regularity of menstrual cycle after giving the interventional treatment.
时间窗: 3,6,9 months
次要结局
- To evaluate the adverse effects of both treatments(3,6,9 months)
