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临床试验/CTRI/2024/05/067094
CTRI/2024/05/067094尚未招募2/3 期

Randomized controlled clinical trial to study the efficacy of Rasonadi Churna on Hyperandrogenism in PCOS affecting menstrual irregularities.

Dr Rekha Chhagan Kuwar1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年5月20日最近更新:
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试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
To evaluate the efficacy of Rasonadi Churna in terms of irregular interval of menstrual periods.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is randomized clinical controlled trial comparing the safety and efficacy of Rasonadi Churna on Hyperandrogenism in PCOC affecting Menstrual irregularities.

Combination of Rasonadi Churna, Dose of 5gm BD with anupan Go-ghruta orally for 3 Months of POCS patients.

Primary outcome will be evaluation of irregular interval of menstrual period during 3 Month and secondary outcome will be effect of Rasonadi Churna on Hyperandrogenism and Insulin resistance in 3 Months.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • •Married and Unmarried patients of PCOS with Rotterdam criteria.

排除标准

  • •Patients having.
  • •Hypogonadotrophic hypogonadism.
  • •Premature ovarian failure.
  • •Congenital adrenal hyperplasia.
  • •Hyperprolactenemia.
  • •Thyroid abnormalities.
  • •Tuberculosis.
  • •Congenital anomalies.

结局指标

主要结局

To evaluate the efficacy of Rasonadi Churna in terms of irregular interval of menstrual periods.

时间窗: 12 Weeks

次要结局

  • - To study the effect of Rasonadi Churna on hyperandrogenesim.(- To study the effect of Rasonadi Churna on hyperandrogenesim and insulin resistance.)

研究者

发起方
Dr Rekha Chhagan Kuwar
申办方类型
Other [self]

研究点 (1)

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