IRCT20181006041252N20CompletedPhase 3
Evaluation of the effect of metformin as an adjunct therapy in mild-to-moderate ulcerative colitis
Sabzevar University of Medical Sciences0 sites84 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 84
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 55 years (—)
- Sex
- All
Inclusion Criteria
- •Patients have ulcerative colitis involving at least the rectosigmoid region with the activity confirmed by colonoscopy at the beginning of the study
- •Patients with ulcerative colitis over 18 years of age
- •Patients with mild to moderate recurrent ulcerative colitis with a disease activity index of 3 to 8 points with symptoms (recurrent episodes) for less than 4 weeks before the study
Exclusion Criteria
- •Patients with Crohn’s disease, diabetic mellitus, heart failure, and severe renal or hepatic failure.
- •Pregnant or lactating women
- •Patients with mild to moderate recurrent ulcerative colitis with a disease activity index of less than 3 and more than 8 points with symptoms (recurrent episodes) for less than 4 weeks before the study
- •Patients with a past history of allergy to metformin
- •Patients treated with systemic corticosteroids, anti-tumor necrosis factor (TNF) or cyclosporine in the last 8 weeks and during the study period
- •Patients with any changes in the oral dose of 5-ASA or 6-mercaptopurine and azathioprine in the last 12 weeks and during the study. In addition, patients taking rectal 5-ASA or steroids 4 weeks before enrollment or during the 8-week study period.
Investigators
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