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临床试验/CTRI/2024/12/078488
CTRI/2024/12/078488招募中Unknown

To study the role of Ayurvedic treatment in prevention of recurrence of abnormal vaginal discharge in reproductive age women: A randomized control trial

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年3月1日最近更新:
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试验速览

阶段
Unknown
状态
招募中
入组人数
300
试验地点
1
主要终点
1. We expect from this study that the recurrence rate in subjects receiving standard treatment followed by Ayurvedic treatment will be lower than standard treatment alone.
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

  1. Recently various studies have attempted to find new approaches in diet and lifestyle to improve vaginal flora like probiotics and vaginal microbiome transplantation. We propose to explore the role of ayurvedic treatment in standard management of abnormal vaginal discharge in improving remission and decreasing recurrence rates.
  2. This study will generate new data with greater volume and diversity to provide the effectiveness of ayurvedic medicines in the management of abnormal vaginal discharge. It will also help us know the side-effects and acceptability to this treatment and hence will guide in formulating guidelines for the use of ayurvedic medicines for use.

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
18.00 Year(s) 至 45.00 Year(s)（—）
性别
Female

入选标准

  • •Sexually active women aged 18 to 45 years with complaints of vaginal discharge, itching vulva, burning sensation and foul smell
  • •Willing to participate in the study and follow up.

排除标准

  • •Women with gross curdy white discharge
  • •Pregnant or lactating women
  • •Women with severe physical illness or any systemic disease such as DM, any severe hepatic, cardiac, renal disease, any acute infection or chronic corticosteroids use
  • •Known HIV infection 5.Any condition on PI discretion.

结局指标

主要结局

1. We expect from this study that the recurrence rate in subjects receiving standard treatment followed by Ayurvedic treatment will be lower than standard treatment alone.

时间窗: Follow up at 1, 3, 6, 12 months

次要结局

  • 1. The study will provide us the side effects & patient acceptability to ayurvedic medicines(2. We will also find out the effect of the ayurvedic medicine on vaginal pH & microflora)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Garima Kachhawa

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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