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IRCT20190712044182N2 IRCT 2019-12-30 Iran University of Medical Sciences Effect of chicoridin on ulcerative colitis The efficacy of chicoridin in improvement of ulcerative colitis symptoms and patients' self-reported well-being 2019-12-21 anticipated 54 Complete https://irct.ir/trial/43809 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: One of the randomization methods is using Excel's RANDBETWEEN function. This function allows us to generate random numbers. To produce a random number in this study with sample size 54, between two numbers 1 and 54 use the = Randbetween function (1,54). This function creates a column of random numbers between 1 and 54. The rand () function selects numbers with equal probability in this interval, so the chance of choosing any number in this interval is equal to the other numbers. This means that each patient is assigned to one of two treatments, respectively. These data are 54 patients randomly assigned to two treatments, 1 and 2 (27 patients each). The sample numbers in the first and second groups are as follows: (15, 6,37,41, 23, 43, 13,35,10, 12,51,28,4,17, 26,38,20,33,11, 48, 36, 39.49, 47.8 34.22) (30, 52,27,19,42,18,9,24,40,53,1, 44, 2, 50, 45, 46,3,7,32,25, 31,54,21, 14,29 16, 5). 3 Ulcerative colitis. Intervention 1: Intervention group: Oral chicoridin, three capsules per day in three divided doses before meals for 8 weeks plus standard treatment for each patient as needed which at least includes oral mesalamine tablets. Intervention 2: Control group: Standard treatment for each patient including at least oral mesalamine tablets. Yes - There is a plan to make this available What will be shared: Information about the main consequences will be shared. When: Start the access period, 6 months after publication of results To whom: Physicians , patients with ulcerative colitis Conditions: Published as an article Where to obtain: mohsen masoodi masoodi47@yahoo.com How to obtain: mail will be sent to the main author or co-response, and in less than 2 week, the available data will send to the individual. Comments:
public Mohsen Masoodi
Colorectal Research Center, Rasoul-e-Akram Hospital, Maziar Mansouri St., Sattarkhan
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 21 6655 3582 masoodi.m@iums.ac.ir Iran University of Medical Sciences scientific Mohsen Masoodi
Colorectal Research Center, Rasoul-e-Akram Hospital, Maziar Mansouri St., Sattarkhan St.
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 21 6655 3582 masoodi.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients 18-80 years old with mild to moderate ulcerative colitis based on Simple Clinical Colitis Activity Index 18 years 80 years Both hospital admission significant comorbidities including liver or kidney diseases pregnancy lactating women K51 Ulcerative colitis Treatment - Drugs Treatment - Drugs Intervention group: Oral chicoridin, three capsules per day in three divided doses before meals for 8 weeks plus standard treatment for each patient as needed which at least includes oral mesalamine tablets. Control group: Standard treatment for each patient including at least oral mesalamine tablets. The efficacy of chicoridin in improvement of ulcerative colitis symptoms and patients' self-reported well-being according to the “Simple Clinical Colitis Activity Index” (SCCAI). Timepoint: 4weeks and 8 weeks after the intervention onset. Method of measurement: Interviews with patients and complete table of “Simple Clinical Colitis Activity Index” (SCCAI). Iran University of Medical Sciences Approved 2019-02-23 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, next to Milad Tower, Hemat highway Tehran Tehran Iran (Islamic Republic of)