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IRCT20181006041252N20 IRCT 2023-11-10 Sabzevar University of Medical Sciences 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 2017-04-24 anticipated 84 Complete https://irct.ir/trial/61667 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is based on permutation blocks. Accordingly, 21 blocks are allocated to patients, in each block 2 from the treatment group and 2 from the B treatment group are placed. Eventually, after completion of the blocks, after blocks are completed, group A is treated with metformin 1000 mg tablets, and group B is treated with placebo tablets, Blinding description: Each person in the study will be assigned codes A and B, and the researcher will only be known of the type of group. The outcome evaluator and participants are unaware of the groups. It should be noted that metformin and placebo are similar in appearance, color, and packaging. 3 Ulcerative colitis. 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 group: Patients in this group consume placebo tablets (prepared in the Iranian Pharmacy Laboratory) for two months after breakfast and evening meals. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Dr. Mahdi Molavi
Heshamatiyeh Hospital, Asadabady Ave., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9613873136 +98 51 4401 1014 molavi.m@gmail.com Sabzevar University of Medical Sciences scientific Dr. Mahdi Molavi
Heshamatiyeh Hospital, Asadabady Ave., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9613873136 +98 51 4401 1014 molavi.m@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) 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 18 years 55 years Both 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. K51 Ulcerative colitis Treatment - Drugs Placebo Intervention group: Patients in this group consume 1000 mg metformin tablet (produced by Tehran Shimi Company) for two months after breakfast and evening meals. Control group: Patients in this group consume placebo tablets (prepared in the Iranian Pharmacy Laboratory) for two months after breakfast and evening meals. 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. Sabzevar University of Medical Sciences Approved 2016-10-04 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city Sabzevar Razavi Khorasan Iran (Islamic Republic of)