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Phase IIb clinical trial on selected strains of probiotic lactobacilli packed as Capsules/Tablets for colonization potential and efficacy against recurrence of Bacterial Vaginosis

A clinical trial to test the colonization potential of selected probiotic strains in women with recurring episodes of Bacterial Vaginosis

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000236
Enrollment
100
Registered
2010-03-30
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- Recurring episodes of Bacterial Vaginosis in women

Interventions

Intervention1: Polyherbal Tablet Praneem/BASANT, WHO drugs metronidazole &amp
clindamycin and Probiotic lactobacillus tablet/gel: All women enrolled having AVDS will be treated for 14 consecutive days with Praneem Polyherbal tablets or Basant tablet or WHO drugs (such as metro

Sponsors

Department of Biotechnology
Lead Sponsor
All India Institute of Medical Sciences, New Delhi
Collaborator
Sir Ganga Ram Hospital, New Delhi
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Women between age groups of 18-45 with regular cycles 2.Clinical history of chronic and/ or recurring episodes of abnormal vaginal dischargre. On pelvic examination,they are seen to have either excessive or unhealthy vaginal discharge. 3.Willing to participate in the study after having been explained about the nature of the body. Willing to return for follow up after 5-7 days of completion of treatment and thereafter on monthly basis for 3 months in part I of study.

Exclusion criteria

Exclusion criteria: 1.Known case of diabetes mellitus. 2. Suspected/confirmed pregnancy. 3.Suspected or known malignancy of reproductive tract 4.Less than 6 weeks since last delivery or abortion 5.H/O severe allergic reaction 6. Abnormalities of vaginal anatomy which will interfere with placement of drug 7. Known systemic diseases, immuno-compromised states 8. Adnexal mass or tenderness 9. Received a course of antibiotic therapy, less than 14 days prior to enrollment 10. Dysfunction uterine bleeding 11.Vaginal polyp

Design outcomes

Primary

MeasureTime frame
Relief from Bacterial Vaginosis judged on the basis of Pelvic examination, pH and Nugent scoreTimepoint: 14 days

Secondary

MeasureTime frame
Colonization of Probiotic lactobacillus judged on the basis of Pelvic examination, pH and Nugent score.Timepoint: 3 months

Countries

India

Contacts

Public ContactProf. G. P. Talwar

The Talwar Research Foundation, Delhi

gptalwar@gmail.com011-29531039, 09312243521

Outcome results

None listed

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