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Role of Antifungals in decreasing disease severity in ulcerative colitis

Role of oral fluconazole in reducing disease activity in patients of active ulcerative colitis : A double blind randomised placebo controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/11/016292
Enrollment
60
Registered
2018-11-09
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: K51- Ulcerative colitis

Interventions

Intervention1: Fluconazole: Oral fluconazole 200 mg twice daily for 2 weeks Intervention2: Fluconazole: 200 mg twice daily orally for 3 weeks Intervention3: Fluconazole: 200mg once a day for 3 weeks C

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Consecutive diagnosed cases of UC who are willing to participate in the study after signing the consent form

Exclusion criteria

Exclusion criteria: 1.Unable to provide informed consent 2Pregnant/ Lactating mother 3.Renal/Hepatic disorder 4.Serious life threatening co morbidity 5.Patients who are exposed to anti-fungal drugs in last 1 month

Design outcomes

Primary

MeasureTime frame
1.Clinical and endoscopic response at 4 wks (Clinical response defined as reduction in UCDAI by 3 points or by 30%) Timepoint: 1.Clinical and endoscopic response at 4 wks (Clinical response defined as reduction in UCDAI by 3 points or by 30%)

Secondary

MeasureTime frame
â?¢ Reduction in fecal calprotectin levels at 4 weeks â?¢ Histological response at 4 week â?¢ Clinical response at 8 weeks â?¢ Any drug toxicity Timepoint: 4 and 8 weeks

Countries

India

Contacts

Public ContactDr Jimil Shah

PGIMER

anuraag2destiny@gmail.com7506228491

Outcome results

None listed

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