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临床试验/CTRI/2023/06/053487
CTRI/2023/06/053487招募中2/3 期

A Randomized Controlled Trial to assess the ovulatory effect of Ashwagandha Ksheerapaka in the management of Haritokt Anapatya Vandhya (Primary Infertility) with special reference to Anovulation (Beeja Dushti).

Dr.Jeny Mukesh Bhatt1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年6月13日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
To assess & compare the ovulatory effect of Ashwagandha Ksheerapaka & Clomiphene Citrate in the management of Haritokt Anapatya Vandhya (Primary Infertility) with special reference to Anovulation(Beeja Dushti).

研究概览

简要总结

The Present Study is a PhD Topic.

By PhD Scholar - DR JENY MUKESH BHATT and Guide Name - DR JAFAR DARUWALE.

Title - A Randomized Controlled Trial to assess the ovulatory effect of Ashwagandha Ksheerapaka in the management of Haritokt Anapatya Vandhya (Primary Infertility) with special reference to Anovulation (Beeja Dushti).

Group A - 50 samples will be given freshly prepared Ashwagandha Ksheerapaka 100 ml once a day early morning (before breakfast) from 5th day to 16th day of menses i.e. for 12 days.

Group B - 50 samples will be given Clomiphene Citrate 50 mg once in a day to be given from 5th day of menses for 5 days.

Total Duration of Trial is 1 year and 6 months.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Open Label

入排标准

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

入选标准

  • Known patients with Primary Infertility with Anovulation.
  • Patients with age group between 18-35 years.
  • Patients having regular or irregular menses.
  • Patients with PCOS.

排除标准

  • Congenital anomalies of uterus,ovaries,cervix,vagina(female reproductive organs).
  • Fibroids,Ovarian Tumour,Premature Ovarian Failure,CA Cervix.
  • Known case of Systemic Diseases like DM,Hypothyroidism,Hyperthyroidism.

结局指标

主要结局

To assess & compare the ovulatory effect of Ashwagandha Ksheerapaka & Clomiphene Citrate in the management of Haritokt Anapatya Vandhya (Primary Infertility) with special reference to Anovulation(Beeja Dushti).

时间窗: at baseline, 4 weeks, 8 weeks and 12 weeks.

次要结局

  • To study the complete literature on ovulation as well as Anapatya Vandhya available in texts.(at baseline, 4 weeks, 8 weeks & 12 weeks.)

研究者

发起方
Dr.Jeny Mukesh Bhatt
申办方类型
Other [self]

研究点 (1)

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