FindTrial
Sign In

To use biochemical properties of vaginal discharge for possible diagnosis of bacterial vaginosis and predict treatment outcome.

Analysis of the diagnostic and/or predictive potential of metabolomics in bacterial vaginosis, its treatment failure, relapse and susceptibilities to other sexually transmitted infections.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/12/016508
Enrollment
40
Registered
2018-12-03
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: N898- Other specified noninflammatory disorders of vagina

Interventions

Intervention1: Secnidazole (2g), Fluconazole (150mg): This is the standard first line treatment as recommended by NACO for syndromic management of vaginal discharge.No experimental drug is being tried

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who are BV positive using Amsel criteria 2. BV positive women in the reproductive age group (18-45 years) 3. Presence of abnormal vaginal discharge

Exclusion criteria

Exclusion criteria: Presence of co-existing STIs contributing to discharge 2. Patients who are HIV positive 3. Iatrogenic or systemic illness or metabolic disorders. 4. Presence of associated co-morbidities 5. Patients who have received oral drugs within the last 4 weeks 6. Patients who have received topical or intravaginal treatment within the last 4 weeks 7. Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
To analyze the microbiota compositiion and metabolic profiles of women with bacterial vaginosis and compare them with health controls.Timepoint: 0, 4 weeks, 1 year/relapse whichever earlier—

Secondary

MeasureTime frame
To explore diagnostic and/or predictive potential of metabolomics by comparing with existing diagnostic modalities.Timepoint: 2 years—

Countries

India

Contacts

Public ContactDr Somesh Gupta

All India Institute of Medical Sciences

someshgupta@hotmail.com01126546626

Outcome results

None listed

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