Health Condition 1: N771- Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 18 years or older Patients with a confirmed diagnosis of Vulvovaginal Candidiasis by high vaginal swab the symptoms evaluated using a numerical rating system based on severity with a minimum VVC Composite Signs Symptoms score of 7 Participants willing to provide written informed consent Participant complies with all clinical trial instructions Commits to all follow-up visits
Exclusion criteria
Exclusion criteria: Pregnant and Lactating women Known or active HIV viral hepatitis B or C Any other sexually transmitted disease Use of antifungal treatments and Estrogen replacement therapy within 7 days before randomization Use of systemic corticosteroid treatments within 30 days before randomization Systemic immunosuppressant treatments within 90 days before randomization History of cervical cancer Moderate to severe hepatic and or renal disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic Cure Clinical Cure Complete resolution of all signs and symptoms of VVC Mycological Cure Negative Candida culture or microscopy result from a vaginal swabTimepoint: Baseline, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Therapeutic CureTimepoint: baseline, day 14, day 28 | — |
Countries
India
Contacts
SRM Medical College Hospital and Research Centre SRMIST