A Randomised Controlled Clinical Trial to evaluate efficacy of Yonidhoopan by Bruhatiphal-Haridradway in management of Yonikandu in relation to Vulvovaginitis.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To reduce pruritis or itching in vulvovaginal region
研究概览
简要总结
This study is a randomised, open labelled, parallel group study to evaluate the efficacy of Yonidhoopan by Bruhatiphal Haridradway in management of Yonikandu in relation to Vulvovaginitis compared with individuals receiving V-Gel for local application. This study involves 66 patients divided 33each into Trial and Control Group. Trial Group is receiving Yonidhoopan twice a day for 7days by Bruhatiphal-Haridradway churna. Control Group is receiving V-Gel for local application twice a day for 7days. Follow up will be done on 10th and 14th day. Primary outcome of the study is to reduce itching in vulvovaginal region. Secondary outcome is to reduce the bacterial flora of vulvovaginitis that is Candida vaginitis, Trichomonas vaginalis, Monilial, E.coli, Bacterial vaginosis and also to reduce pain, redness, scratch marks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Married woman Age 20 to 40 years Clinical sign symptoms of vulvovaginitis that is itching pain in vulvovaginal region redness scratch marks Microscopically positive specimen for Candida albicans Trichomonas Monoliasis E coli.
排除标准
- •Pregnant women Immuno compromised patients Suspected cases of carcinoma of cervix endometrial carcinoma Known case of Asthma Tuberculosis positive Senile vaginitis Systemic illness like Diabetes mellitus Severe Anaemia Liver disorder Hypertension.
结局指标
主要结局
To reduce pruritis or itching in vulvovaginal region
时间窗: 1 month
次要结局
- Reduction in Bacterial flora of vulvovaginitis that is Candida vaginitis Trichomonas vaginalis Monilial E.coli Bacterial vaginosis(To reduce pain redness scratch marks)