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Adding lactic acid on a single dose metronidazole for treating Thai women with bacterial vaginosis: a randomized trial

Adding lactic acid on a single dose metronidazole for treating Thai women with bacterial vaginosis: a randomized trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20231106004
Enrollment
110
Registered
2023-11-06
Start date
2023-11-22
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Thai non-pregnant women being diagnosed with bacterial vaginosis non-pregnant women, bacterial vaginosis, Thai, metronidazole, lactic acid

Interventions

metronidazole 2g plus lactic acid 7 days,metronidazole 2g
Active Comparator Drug,Active Comparator Drug
metronidazoleandlactic,metronodidazole

Sponsors

Bayer, Thailand
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Non-pregnant Thai women 2. Aged 18-50 years 3. Diagnosis with BV by Amsel criteria

Exclusion criteria

Exclusion criteria: 1. Having immunocompromised conditions such as HIV infection 2. Allergic to metronidazole 3. Not coming at the second visit 4. Not any single use of lactic acid

Design outcomes

Primary

MeasureTime frame
Culture for Lactobacilli at enrollment and 2 weeks colony-forming unit

Secondary

MeasureTime frame
Symptoms (vaginal discharge, vaginal mal-odor, vaginal discomfort) enrollment and 2 weeks 0-4/interview,Amsel criteria(pH, homogeneous discharge, whif, clue cell) enrollment and 2 weeks yes,no/ clinical and microscopic assessment,Time to cure evaluation at 1 week days/interview,Side effects evaluation at 1 week yes,no/interview,Satisfaction evaluation at 2 weeks 0-10/interview,Recurrence 2, 4, 6 months yes,no/telephone

Countries

Thailand

Contacts

Public ContactChenchit Chayachinda

Faculty of medicine Siriraj Hospital, Mahidol University

chenchit.cha@mahidol.ac.th66863123623

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026