Clinical study of capsule containing lactobacillus strains in adult women subjects suffering from BacterialVaginosis.

Completed

• Conditions: Bacterial Vaginosis

• Registration Number: CTRI/2015/04/005714
• Lead Sponsor: Spectrum Clinical Research Pvt Ltd

Brief Summary

This is Prospective, Randomized, Double blind, parallelgroup, Placebo controlled clinical study of capsule containing lactobacillusstrains in adult women subjects suffering from Bacterial Vaginosis.

Adult female subjects will be screened for presencebacterial vaginosis using Amsel’s criteria after obtaining written informedconsent. Eligible subjects will be randomized to either of the two groups –Group 1 (Test group) or Group 2 (Placebo group) using computer generatedrandomization schedule. Enrolled subjects will be provided capsules for dailyconsumption for 4 weeks according to their randomization sequence along withthe instructions of use. Safety and efficacy assessment will be done on day 7,14, 28, 42 and 56. Investigational product compliance will be checked on days7, 14 and 28 by counting the number of capsules consumed and time since lastvisit.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-27
• Last Update Posted: 2015-07-14

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Symptoms of vaginal discharge with Bacterial Vaginosis diagnosed by Amsel’s criteria.
• Asymptomatic but on clinical examination presence of abnormal vaginal discharge with Bacterial Vaginosis diagnosed by Amsel’s criteria.
• 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 vaginosis	4 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of IP in cases of bacterial vaginosis	4 weeks

Trial Locations

Locations (1)

Spectrum Healthcare; 🇮🇳 Mumbai, MAHARASHTRA, India

Spectrum Healthcare

🇮🇳Mumbai, MAHARASHTRA, India

Dr Sudha Marwah

Principal investigator

02222846357

smarwah@spectrumhealthcare.in