Clinical evaluation of the effect of panchavalkal arka in kaphaja yoni vyapat(vulvovaginal candidiasis)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Major symptoms like curdy white discharge, vulval and vaginal itching should be cured.
研究概览
简要总结
This study is an open labeled single arm clinical trial to evaluate the effect of panchavalkal arka in 30 patients with Kaphaja yoni vyapat (vulvo-vaginal candidiasis).The study will be conducted at in/out patient department of prasuti tantra and stree roga in Sri Dharmsthala Manjunatheswara ayurveda hospital Hassan, karnataka.Patients will be advised to wash vulva with 10 ml panchavalkal arka diluted with 100 ml distilled lukewarm water twice a day for 7 days and assessment will be done at baseline,follow up on 7th and 15th day .
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
- •1.Married women 2.Subjects fulfilling diagnostic criteria and having local signs and symptoms of kaphaja yoni vyapat as described in texts such as shweta and picchilasrava , yoni kandu and alpa vedana 3.wet vaginal smear postive for candida albicans or microscopically positive for pseudohyphea.
排除标准
- •1.Pregnant and lactating women 2.subjects positive for HIV,VDRL,HBsAG 3.Systemic diseases like diabets mellitus 4.Subjects on hormonal medications like contraception or regulation of menstruation 5.Subjects who have had anti fungal coverage within 1 month or corticosteriods for less than past 6 months.
结局指标
主要结局
Major symptoms like curdy white discharge, vulval and vaginal itching should be cured.
时间窗: Assessment will be done at baseline,follow up on 7th and 15 th day.Vaginal smear will be repeated on 15 th day for result.
次要结局
- Other symptoms like backache,pain during coitus should also be reduced.(15 days)
