Health Condition 1: N898- Other specified noninflammatory disorders of vagina
Conditions
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 trie
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who are BV positive using the Gold standard for BV diagnosis- Nugentâ??s score 2. BV positive women in the reproductive age group (18-45 years) 3. Presence of abnormal vaginal discharge
Exclusion criteria
Exclusion criteria: 1. Presence of co-existing STIs contributing to discharge 2. Patients who are HIV positive 3. Iatrogenic or systemic illness 4. Presence of associated co-morbidities (diabetes, auto immune conditions, chronic illness requiring regular drug intake). 5. Patients receiving oral drugs within the last 3months (antibiotics / regular use of oral drugs) 6. Patients receiving topical treatment within the last 2 weeks (intra-vaginal) 7. Douching/ use of vaginal hygiene products in the last 3 days. 8. Use of oral contraceptives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to identify the microbiota and metabolite profiles of the vaginal discharge in patients with BV and compare them that of healthy controls.Timepoint: 0, 1 week, 1 months, 3 months, 6 months, 9 months and 12 months and at the time of relapse if any. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the potential of metagenomics and metabolims as diagnostic tool for BVTimepoint: 3 years | — |
Countries
India
Contacts
Public ContactApoorva
All India Institute of Medical Sciences
Outcome results
None listed