Clinical study of capsule containing lactobacillus strains in adult women subjects suffering from BacterialVaginosis.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Bacterial Vaginosis
- Registration Number
- CTRI/2015/04/005714
- Lead Sponsor
- Spectrum Clinical Research Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
1. Symptoms of vaginal discharge with Bacterial Vaginosis diagnosed by Amselâ??s criteria.
2. Asymptomatic but on clinical examination presence of abnormal vaginal discharge with Bacterial Vaginosis diagnosed by Amselâ??s criteria.
3. Willing to participate in the study after informed consent.
Exclusion Criteria
1.Menopausal women
2.Pregnant women
3.Malignancy of reproductive tract
4.Less than 6 weeks since last delivery and abortion
5.H/O severe allergic reaction
6.Immuno compromised state
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of IP in cases of bacterial vaginosisTimepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method To evaluate the safety of IP in cases of bacterial vaginosisTimepoint: 4 weeks