A clinical trial to study the effects of a lactobacilli preparation in bacterial vaginosis, HIV infectivity and vaginal immunity in healthy women and in subjects with bacterial vaginosis
- Registration Number
- CTRI/2007/091/000022
- Lead Sponsor
- CD Pharma India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 140
Healthy women of reproductive age group over 18 years
Bacterial vaginosis to be excluded by Nugent score (healthy patients)
b.Bacterial vaginosis diagnosis is based on the Nugent method (in patients with bacterial vaginosis)
Exclusion of any other vaginal infection by standard diagnostic procedure.
Written informed consent
Post menopausal women
Pregnant women
Abnormal uterine bleeding (not including cervical contact bleeding on sampling) or vaginal bleeding of unknown origin.
AIDS patients or patients with any kind of cancer or tumor
Diabetes mellitus
Drug addiction
Antibiotic use (local or systemic) in the previous 20 days.
Use of any vaginal medication in the previous 7 days.
Participation in any other study 30 days before beginning of the present study.
Known or suspected hypersensitivity to any of the ingredients of the trial medication.
No informed consent.
Patient not willing to comply with the trial instructions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method