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临床试验/CTRI/2025/04/085859
CTRI/2025/04/085859尚未招募4 期

Effects of Lifestyle Modification with Myoinositol and Berberine versus Myoinositol and Metformin in Women with Polycystic Ovary Syndrome: A Prospective Randomized Study: A case report

Dr Sathyapriya Balasubramaniyan1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年5月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
240
试验地点
1
主要终点
Clinical, Metabolic, hormonal parameters

研究概览

简要总结

This study aimed to evaluate the impact of Lifestyle Modification with Myoinositol and Berberine versus Myoinositol and Metformin on Clinical, hormonal, carbohydrate and lipid parameters in women with PCOS at the end of three months. this is proposed to be a multi centre, prospective randomized study.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • BMI 18 to 35 PCOS as defined by Rotterdams criteria and all 4 phenotypes Mild to moderate male factor TMSC more 3 million.

排除标准

  • Endometriosis More than 10 years of infertility Low ovarian reserve Severe male factor infertility Bilateral tubal block DM Patients already on the same medications prior to consultation.

结局指标

主要结局

Clinical, Metabolic, hormonal parameters

时间窗: 3 months

次要结局

  • To assess improvement in cycle regularity and rate of spontaneous conception(at start of study and at the end of three months)

研究者

发起方
Dr Sathyapriya Balasubramaniyan
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Sathyapriya Balasubramaniyan

A4 Hospital and Fertility centre Pvt Ltd

研究点 (1)

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