跳至主要内容
临床试验/CTRI/2024/08/071776
CTRI/2024/08/071776尚未招募不适用

To study the efficacy of Cabergoline as an adjunct to Metformin in management of overweight & obese women with PCOS

未提供1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Regularization of menses

研究概览

简要总结

Women with PCOS have menstrual irregularities, hyperandrogenism and elevated level of inflammatory markers such as CRP , interleukins (IL-6, 18) TNF alpha, WBC count, chronic inflammatory state is further exacerbated by factors such as obesity and hyperinsulinemia, elevated level of inflammatory markers and oxidative stress indicate endothelial cell damage , Metformin alone is not as effective as in combination with other insulin sensitizer in improving glycolipid parameters in obese PCOS, Cabergoline an antiangiogenic reduces inflammatory markers in patients with prolactinoma and endometriosis. Cabergoline improves insulin sensitivity, leads to weight reduction and normalizing menstrual irregularities and androgen level in PCOS patients. We aim to evaluate the effect of add on Cabergoline with standard metformin on hormonal profile and menstrual regulation in women with overweight/obese PCOS.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
16.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Women diagnosed with PCOS by Rotterdam criteria, Age 16-35 years, BMI 23-35 kg/m2, Willing to participate in the study.

排除标准

  • Patients with other endocrine disorders such as Cushing’s Syndrome, acromegaly, pituitary adenoma, etc , Women planning pregnancy in next 6 months, Intolerability to cabergoline, Not willing to participate.

结局指标

主要结局

Regularization of menses

时间窗: 6 months

次要结局

  • Reduction in serum inflammatory markers(1, 3, 6 months)
  • Improvement in glycemic parameter(1, 3, 6 MONTHS)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Garima Kachhawa

AIIMS, New Delhi

研究点 (1)

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