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IRCT20190701044062N5 IRCT 2021-04-03 Tabriz University of Medical Sciences Effect of saffron solution on ulcerative colitis Comparison of the effect of saffron enema with placebo in controlling the disease of patients with ulcerative colitis based on Mayo score 2020-10-22 anticipated 60 Complete https://irct.ir/trial/51493 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of patients to two groups will be done using graph pad software. Random numbers will only be available to the head nurse until the end of the study. Patients and specialists evaluating the severity of the disease and the statistical analyst will be blind to the allocation of individuals to study groups until the end of the study. And the desired solutions are marked with A and B and will be provided by the nurse, Blinding description: Patients and specialists evaluating the severity of the disease and the statistical analyst will be blind to the allocation of individuals to study groups until the end of the study. 0 (exploratory trials) Ulcerative Colitis. Intervention 1: Intervention group: The intervention group is prescribed 2 grams of mesalazine tablets and saffron solution as a solution of 300 mg of saffron in 50 cc of water, daily for 4 weeks and the severity of the disease Will be evaluated by usin.g mayo score before and after the study. Intervention 2: Control group: The control group is prescribed 2 grams of mesalazine tablets and saffron color's solution as a solution of 300 mg of saffron color in 50cc of water, daily for 4 weeks and the severity of the disease will be elevated by using mayo score before and after the study. 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 All authors are required for publication and no further information is required
public Manouchehr Khoshbaten
Imam Reza Hospital Clinic, Golgasht St.
Tabriz Iran (Islamic Republic of) 5154751637 +98 41 3337 2088 mkhoshbaten@yahoo.com Tabriz University of Medical Sciences scientific Manouchehr Khoshbaten
Imam Reza Hospital Clinic ,Golgasht St.
Tabriz Iran (Islamic Republic of) 5154751637 +98 41 3337 2088 mkhoshbaten@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients who's disease is diagnosed recently or recent relapce Patients who can tolerate enema no limit no limit Both Patients with good controlled disease Patients who can't tolerate enema Patients with associated disease: Crohn, Intermediate colitis, CMV, Pseudomembrano colitis, Heart failure, Renal failure, PSC K51 Ulcerative colitis Treatment - Drugs Placebo Intervention group: The intervention group is prescribed 2 grams of mesalazine tablets and saffron solution as a solution of 300 mg of saffron in 50 cc of water, daily for 4 weeks and the severity of the disease Will be evaluated by usin.g mayo score before and after the study Control group: The control group is prescribed 2 grams of mesalazine tablets and saffron color's solution as a solution of 300 mg of saffron color in 50cc of water, daily for 4 weeks and the severity of the disease will be elevated by using mayo score before and after the study. Disease activity based on Mayo score. Timepoint: Assessment of disease activity at the beginning of the study and 28 days after the start of saffron enema solution. Method of measurement: Mayo Score. Frequent defecation. Timepoint: Evaluation of stool frequency at the beginning of the study and 28 days after starting saffron enema solution. Method of measurement: Mayo Score. Rectal bleeding. Timepoint: Evaluation of rectal bleeding at the beginning of the study and 28 days after starting saffron enema solution. Method of measurement: Mayo score. Endoscopic findings. Timepoint: Evaluation of endoscopic findings at the beginning of the study and 28 days after starting saffron enema. Method of measurement: Mayo score. Tabriz University of Medical Sciences Approved 2020-08-01 Ethics Committee of Tabriz University of Medical Sciences The central building of Tabriz University of Medical Science,Golgasht St.,Azadi St. Tabriz East Azarbaijan Iran (Islamic Republic of)