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临床试验/CTRI/2019/06/019655
CTRI/2019/06/019655已完成不适用

A single arm pre and post study to assess the combined effect of Aragvadha twak kashaya yoni prakshalana and Aragvadha twak kashaya internal administration in Vaginal candidiasis (slaismiki yonivyapat)

DrVandanaKVasudevan1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年7月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Discharge scale more than mild

研究概览

简要总结

This study is a single arm, opren label, pre and post trial on the efficacy of Aragvadha twak kashaya yoni prakshalana and aragvadha twak kashaya internal administration for 40 days in 20 patients with vaginal candidiasis that will be conducted in a single center in India. The primary outcome measures will be discharge scale and 5-D Itch scale at 10th and 40th days. The secondary outcomes will be candidial spore count at 10th and 40th days.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Diagnosed with Candidiasis.

排除标准

  • Pregnancy Known case of Diabetes mellitus Known case of Sexually Transmitted Disease/Pelvic Inflammatory Disease Known case of Malignancies Under Oral Contraceptive Pills.

结局指标

主要结局

Discharge scale more than mild

时间窗: AT 10th and 40th days

5-d Itch Scale more than mild

时间窗: AT 10th and 40th days

次要结局

  • Candidial Spore count(at 10th and 40th days)

研究者

发起方
DrVandanaKVasudevan
申办方类型
Other []

研究点 (1)

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