Skip to content

A study to compare the effectiveness and safety of combined oral and vaginal medicine versus oral medicine alone or vaginal medicine alone for treating vaginal yeast infections

Efficacy and Safety of Single-Dose Oral Azithromycin Plus Clotrimazole-Clindamycin Pessary versus Two-Dose Fluconazole versus Clotrimazole-Clindamycin Pessary Alone for Vulvovaginal Candidiasis: A Randomized, Parallel-Arm Comparative Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100796
Enrollment
63
Registered
2026-01-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: N771- Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere

Interventions

Intervention1: Single dose azithromycin: Single dose azithromycin 1 gm oral plus Clotrimazole plus clindamycin Pessary Intravaginally for 5 days Control Intervention1: fluconazole: Two doses of fluco

Sponsors

Srm
Lead Sponsor

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

MeasureTime 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

MeasureTime frame
Therapeutic CureTimepoint: baseline, day 14, day 28

Countries

India

Contacts

Public ContactDr Kumaravel J

SRM Medical College Hospital and Research Centre SRMIST

kumaravelkp1992@gmail.com9943626929

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026