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To compare the efficacy of Itraconazole and Fluconazole in Vulvovaginal candiasis

A study on evaluation of the efficacy of Itraconazole versus Fluconazole in Vulvovaginal Candidiasis compared in different species of Candida

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/022178
Enrollment
160
Registered
2019-11-27
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: N771- Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere

Interventions

Intervention1: Itraconazole: Per oral Dose 200mg BD for 1 day Control Intervention1: Fluconazole: Per oral Dose 150mg Stat on same day

Sponsors

Institute of Venereology Madras Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 160 married women with vulvovaginal candidiasis attending the venereology OPD during the study period. Those who are giving consent to participate in the study. Those who are willing for follow up.

Exclusion criteria

Exclusion criteria: Pregnant women and women in the puerperal period. Patients with Chronic or Recurrent Vulvovaginal Candidiasis. Patients who have received systemic or topical antifungal treatment in the past 1 month. Patients with concurrent bacterial, viral or trichomonal vaginal infection. Patients with known allergy to azole drugs. Patients with coexistent Liver disorders.

Design outcomes

Primary

MeasureTime frame
Clinical effectiveness will be recorded as cure, improvement, failure and relapse as follows at Day 7: Cure: Complete disappearance of all signs and symptoms Improvement: Improvement or partial disappearance of signs and symptoms Failure: No change or worsening of signs and symptoms Relapse: Reappearance of signs and symptoms after documented cure had occurred. Timepoint: Day 7

Secondary

MeasureTime frame
Clinical effectiveness will be recorded as cure, improvement, failure and relapse as follows: Cure: Complete disappearance of all signs and symptoms Improvement: Improvement or partial disappearance of signs and symptoms Failure: No change or worsening of signs and symptoms Relapse: Reappearance of signs and symptoms after documented cure had occurred. Timepoint: Day 21

Countries

India

Contacts

Public ContactDr S Kalaivani

Institute of Venereology, OP no. 119, Madras Medical College

drskalai@gmail.com

Outcome results

None listed

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