Further study on upapluta yonivyapada wsr to vulvovaginitis during pregnancy and its management with panchavalkaladi formulation
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Return of pH towards normal value
研究概览
简要总结
The study is randomised control clinical study to evaluate efficacy of Panchavalkaladi Varti in group A and Panchavalkaladi ointment in group B, group C has control group of Clotrimazole 100 mg Clindamycin100 mg vaginal suppository.The primary outcome measures the changes in subsidence of clinical signs and symptoms measured at baseline. Absence of pathogen in wet slide study,Vaginal swab culture becomes sterile and absence of recurrence during follow up. The study period is for 14 days and Panchavalkaladi Varti will be given in dosage of 1gm 1tab twice daily per vaginally, Panchavalkaladi ointment will be given in dosage of 5gm twice daily per vaginally and Clotrimazole 100 mg Clindamycin100 mg vaginal suppository will be given once daily.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 19.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •After completion of first Trimester of pregnancy Age 19 to 40 years with different parity.
- •White discharge present during examination.
- •Inflammation present in vulva and vagina.
- •Pathogens present in wet slide study and vaginal swab culture.
排除标准
- •Age below 19 yrs or above 40 yrs with non specific vulvovaginitis Hypersensitivity to drug and inability to conform the protocol Women with severe physical illness, any organic pathology hepatic cardiac renal disease and any acute infection of any system Women suffering from any systemic disease like Diabetes TB STD and HIV First trimester of pregnancy.
结局指标
主要结局
Return of pH towards normal value
时间窗: 14 days
Improvement of signs symptoms
时间窗: 14 days
Absence of pathogen in wet slide study
时间窗: 14 days
Vaginal swab culture becomes sterile
时间窗: 14 days
Observation of absence of clinical features
时间窗: 14 days
次要结局
- improvement of itching and redness in vagina(14 days)