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IRCT20231029059892N1 IRCT 2023-11-20 Arak University of Medical Sciences Comparison between combined oral and topical 5-ASA versus topical 5-ASA on ulcerative proctitis. Comparison between topical 5-ASA versus combined oral and topical 5-ASA for the treatment of ulcerative proctitis. 2023-11-21 anticipated 64 Complete https://irct.ir/trial/73546 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization has been done based on the 6 permutation block method taken from Randomization.org and the patients have been divided into two groups A (local treatment) and B (local and oral combination), Blinding description: The study is a triple-blind type. The patients do not know about the assignment of the groups, and the doctor and also the data analyst do not know about the assignment of the study groups. Pharmaceuticals are provided by a third party who is a pharmacy staff, and the researcher himself is informed of the medicinal contents according to the code on the package. 2 Ulcerative proctitis. Intervention 1: Intervention group 1: Patients treated with Mesalazine suppositories at the rate of one gram per day for 6 months. Intervention 2: Intervention group 2: Patients treated with oral Mesalazine at the rate of 3 grams per day along with Mesalazine suppositories of 1 gram per day for 6 months. 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 Due to the incompleteness of the study, no decision has been made yet.
public Esmaeil Mirshafiee
Amiralmomenin hospital, Arak
Arak Iran (Islamic Republic of) 3848176941 +98 86 3836 0000 esmaeilmirshafiee@gmail.com Arak University of Medical Sciences scientific Esmaeil Mirshafiee
Amiralmomenin hospital, Arak
Arak Iran (Islamic Republic of) 3848176941 +98 86 3836 0000 esmaeilmirshafiee@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) All people who have been diagnosed with ulcerative proctitis through colonoscopy and histology during the years 1398-1402. Patients over 15 years old 15 years no limit Both Patients with salicylate allergy Active peptic disease A proven coagulation problem Pregnant and lactating women Significant liver and kidney disease K51.2 Ulcerative (chronic) proctitis Treatment - Drugs Treatment - Drugs Intervention group 1: Patients treated with Mesalazine suppositories at the rate of one gram per day for 6 months. Intervention group 2: Patients treated with oral Mesalazine at the rate of 3 grams per day along with Mesalazine suppositories of 1 gram per day for 6 months. Severity of disease activity. Timepoint: Start of study and 3 and 6 months later. Method of measurement: Simple Clinical Colitis Activity Index (SCCAI) And Disease Activity Index (DAI). Response to treatment. Timepoint: Start of study and 6 months later. Method of measurement: Colonoscopy and Biopsy. Laboratory criteria. Timepoint: Start of study and 3 and 6 months later. Method of measurement: Blood test. Arak University of Medical Sciences Approved 2023-09-26 Ethics committee of Arak University of Medical Sciences Arak university of medical sciences, Arak Arak Markazi Iran (Islamic Republic of)