CTRI/2019/09/021403尚未招募不适用
Comparative Study of Metformin versus Myoinositol in Polycystic Ovarian Syndrome patients
Swati Jain1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2019年9月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- •To compare the EFFECTIVENESS of Metformin versus Myoinositol in Polycystic ovarian syndrome patients in terms of weight reduction, Ferriman Gallwey score, menstrual cycle pattern after 3 months. After 6 months, complete radiological, biochemical and anthropometric reassessment will be done.
研究概览
简要总结
- Patients attending the gynaecology OPD with clinical features suggestive of PCOS (menstrual abnormalities, obesity, acne, hirsuitism, acanthosis nigrans) will be selected after detailed history and clinical examination.
- Anthropometric examination will be done in terms of weight, height , WHR, BMI.
- They will further be subjected to biochemical investigations and ultrasonography to confirm diagnosis.
- Subjects who are eligible according to inclusion criteria will be enrolled in the study after written and informed consent.
- The patients will be randomised by envelope method.
- There will be 2 groups, one group will be getting Metformin 500mg (Me)trice daily and the other group will be getting Myoinositol 1 gram (My) twice daily.
- Monthly follow up will be there in terms of compliance, clinical improvement.
- Every 3 monthly, there will be a follow up in terms of biochemical improvement as well as clinical.
- After 6 months, patients will be investigated completely and accroding to our objectives, clinical biochemical radiological features and side effects will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 15.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •â€¢All the females of age group 15-40 years fulfilling the Rotterdam’s criteria.3 •According to Rotterdam’s Criteria the affected must have :(atleast 2 out of 3) (A) Oligovulation and /or anovulation .
- •(B)Hyperandrogenism(clinical/or biochemical) .
- •(C)Polycystic-ovaries,identified sonographically.
排除标准
- •1.Patients already on other drug treatment for PCOS (like oral contraceptive pills) 2.Deranged kidney or liver function tests
- •Thyroid disorders 4.Known hypersensitivity to drugs
- •Galactorrhoea
- •Patient on any infertility treatment/fertility enhancing drugs
- •Established cases of diabetes mellitus.
结局指标
主要结局
•To compare the EFFECTIVENESS of Metformin versus Myoinositol in Polycystic ovarian syndrome patients in terms of weight reduction, Ferriman Gallwey score, menstrual cycle pattern after 3 months. After 6 months, complete radiological, biochemical and anthropometric reassessment will be done.
时间窗: Follow up will be done at 3rd and 6th month
次要结局
- 1.To identify patients of PCOS patients by Rotterdam’s criteria.(2.To study the role of Metformin in PCOS patients in terms of clinical improvement ,biochemical correction and radiological parameters .)
研究者
研究点 (1)
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