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

A Prospective, Randomized, Double blind, parallel group, Placebo controlled clinical study of capsule containing lactobacillus strains in adult women subjects suffering from Bacterial Vaginosis. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/04/005714
Enrollment
10
Registered
2015-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Bacterial Vaginosis

Interventions

Intervention1: Lactobacillus Capsule: Lactobacillus spp. For oral application in capsule form to be once taken daily for 4 weeks Control Intervention1: Placebo: oral application in capsule form to be

Sponsors

Spectrum Clinical Research Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of IP in cases of bacterial vaginosisTimepoint: 4 weeks

Secondary

MeasureTime frame
To evaluate the safety of IP in cases of bacterial vaginosisTimepoint: 4 weeks

Countries

India

Contacts

Public ContactSanjay Vekariya

Spectrum Healthcare

smarwah@spectrumhealthcare.co.in02222846357

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026