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Metformin as an adjunct therapy in mild-to-moderate ulcerative colitis

Evaluation of the effect of metformin as an adjunct therapy in mild-to-moderate ulcerative colitis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181006041252N20
Enrollment
84
Registered
2023-11-10
Start date
2017-04-24
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Ulcerative colitis. Ulcerative colitis

Interventions

Intervention 1: Intervention group: Patients in this group consume 1000 mg metformin tablet (produced by Tehran Shimi Company) for two months after breakfast and evening meals. Intervention 2: Control

Sponsors

Sabzevar University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mahdi Molavi

Sabzevar University of Medical Sciences

molavi.m@gmail.com+98 51 4401 1014

Outcome results

None listed

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