Metformin as an adjunct therapy in mild-to-moderate ulcerative colitis
- Conditions
- lcerative colitis.Ulcerative colitis
- Registration Number
- IRCT20181006041252N20
- Lead Sponsor
- Sabzevar University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 84
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
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determining disease activity index (DAI). Timepoint: Before the intervention and two months after the intervention. Method of measurement: Mayo Score/Disease Activity Index (DAI) for Ulcerative Colitis.
- Secondary Outcome Measures
Name Time Method