A clinical trial to compare the effect of a herbal formulation WH- 1 with Fluconazole, Tinidazole & FAS-3 kit in female patients with vaginitis.
- Registration Number
- CTRI/2009/091/000514
- Lead Sponsor
- Dr. V.R. Bapat,Ayurvedic Consultant# 375 First B main.First Phase, Girinagar,Bangalore 560085Tel: 080 ? 26720139E mail : vrbapat@yahoo.co.in
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
After getting the IERB approval.
Married women in the age of 18 to 60 years.
Patients/Subjects diagnosed to have vaginitis.
Subjects proven to be eligible through clinical, biochemical examination.
?No clinical evidence of hepatic or renal impairment.
?Subjects who have given written informed consent.
?Female patients / subjects who have given consent for their partner to be included in trial
Pregnant & lactating women.
Chronic disorder such as cardiac (hypertension uncontrolled, arrhythmia), diabetes and endocrine dysfunction (thyroid uncontrolled) as assessed through clinical examination / lab investigations.
Women with multiple partners.?
Subjects with h/o smoking, alcohol & drug dependence etc.
History of Allergy to herbal medication.
Participating in any other study within six weeks preceding day one of the study.
?Patients currently on medication such as Metronidazole & other antifungal drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy and safety of polyherbal preparation WH-1 with Fluconazole, Tinidazole and FAS-3 kit for vaginitis.Timepoint: day 14
- Secondary Outcome Measures
Name Time Method To evaluate the spectrum of activity of polyherbal formulation WH-1 against various organisms causing vaginitis.<br><br>Timepoint: on day 14