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临床试验/CTRI/2024/06/069357
CTRI/2024/06/069357尚未招募3 期

A randomized controlled trial of add on effect of Pippalyadi Churna with Lodhradi Yonivarti in the management of Kaphaj Yonivyapad with special reference to Vaginitis.

Ashwini Ramchandra Metangale1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
114
试验地点
1
主要终点
Overall assessment of improvement by add on effect of Pippalyadi churna with Lodhradi Yonivarti in the management of Kaphaj Yonivyapad with percentage reduction in Amount of vaginal discharge, consistency,Smell, Vaginal Itching.

研究概览

简要总结

This study is randomised open labelled parallel group multicentre trial to study the add on effect of Pippalyadi churna 5gms orally and Lodhradi Yonivarti 3gms locally with Lodhradi Yonivarti alone in the patients of Kaphaj Yonivyapad . Trial will be conducted on two centres in India. Primary outcome measures will be relief in the syptoms of Kaphaj Yonivyapad on 30th day as per subjective criteria and secondary outcome measures will be relief in the symptoms of Kaphaj Yonivyapad on 7th and 15th day as per subjective criteria.

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 50.00 Year(s)(—)
性别
Female

入选标准

  • Patient within 18-50 years of age group
  • Only married patients willing to participate in the trial.
  • Patients having sign and symptoms of Kaphaj Yonivypad.

排除标准

  • Unmarried patients
  • Pregnant women
  • Post menopausal women 4.STD 5.Patients on oral contraceptive pills and IUCD
  • Patients with major illness like HT, DM, TB etc
  • Any type of Malignancy.

结局指标

主要结局

Overall assessment of improvement by add on effect of Pippalyadi churna with Lodhradi Yonivarti in the management of Kaphaj Yonivyapad with percentage reduction in Amount of vaginal discharge, consistency,Smell, Vaginal Itching.

时间窗: Day 0, day 7, Day 15, Day 30

次要结局

  • Evaluate the total improvement by Add on effect of Pippalyadi churna with Lodhradi Yonivarti in the symptoms of Kaphaj Yonivyapad i.e. Amount of vaginal discharge, Consistency, Smell, Vaginal itching by using objective criteria Vaginal culture & vaginal pH.(Before treatment i.e. 0th day & after treatment i.e. 30th day)

研究者

发起方
Ashwini Ramchandra Metangale
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ashwini Ramchandra Metangale

Government Ayurved College Nagpur

研究点 (1)

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