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临床试验/CTRI/2019/03/018306
CTRI/2019/03/018306已完成Unknown

A prospective randomised comparative study of metformin versus myoinositol plus d-chiroinositol combination therapy in polycystic ovarian syndrome

Dr Sukhmani Jaura1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年3月29日最近更新:

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)

研究者

发起方
Dr Sukhmani Jaura
申办方类型
Other [self]

研究点 (1)

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