]>
IRCT20121212011738N3 IRCT 2022-10-13 Tabriz University of Medical Sciences The effect of Montelukast in reducing disease recurrence in patients with ulcerative colitis Determining the effect of Montelukast in reducing disease recurrence in patients with moderate to severe ulcerative colitis during the period of gradual reduction of glucocorticoid dose. 2022-10-12 anticipated 160 Complete https://irct.ir/trial/65949 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be done using Graphpad software. The randomization unit is individual. So that the graphpad software will present the letter A (for the intervention group) and the letter B for the control group for two groups of our patients. This list will be in the hands of the secretary of the department and until the end of the study, only he will know about the allocation of people. Patients will be directed to one of the two groups A or B based on the list by the secretary of the department according to their visit to the clinic. The department secretary will not be involved in other research areas, Blinding description: The study will be triple-blind, in which the patient, the person evaluating the effects of the intervention, and the statistician will be unaware of the assignment of the groups. For blinding, the placebo will be prepared in the same packaging as the original drug, and the letters A and B will be used by the secretary of the department for the cans of drugs and placebo. And the contents of the cans will remain secret until the end of the study and only the department secretary will know about the contents of cans A and B. 3 Ulcerative colitis. Intervention 1: Intervention group: prescribing Montelukast 10 mg tablets, Abidi Pharmaceutical Company, once daily for 16 weeks. Intervention 2: Control group: Placebo drug administration for 16 weeks. 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 Nezamdiba Mehran
No.41 , Gulshan Boulevard, Tejalai Square
Tabriz Iran (Islamic Republic of) ۳۳۳۳۶۶۴۵۵۱ +98 41 3347 8021 mndiba59@gmail.com Tabriz University of Medical Sciences scientific Kurosh Masnadi Shirazi
Gastrointestinal Research Center ، Emamreza hospital, Golgasht st.
Tabriz Iran (Islamic Republic of) ۳۳۳۳۴۵۶۰۶۹ +98 41 1334 7554 masnadik@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) All patients with moderate to severe ulcerative colitis Age 18 to 75 years Involvement beyond the rectosigmoid Treated with a high dose of corticosteroid 40-60 mg daily In the stage of clinical remission Candidate for tapering corticosteroid dose 18 years 75 years Both Age less than 18 Age more than 75 Severely ill patients need hospitalization and special measures Pregnant or lactating women Suffering from systemic diseases including heart, kidney, lung or liver failure Patients with impaired level of consciousness patients with Primary sclerosing cholangitis (PSC) patients with eosinophilic colitis patients with psychological diseases patients receiving anti-TNF drugs or cyclosporine K51 Ulcerative colitis Treatment - Drugs Treatment - Drugs Intervention group: prescribing Montelukast 10 mg tablets, Abidi Pharmaceutical Company, once daily for 16 weeks. Control group: Placebo drug administration for 16 weeks Remaining in a state of clinical remission. Timepoint: Every 2 weeks from the start of tapering the dose of corticosteroids until 6 weeks after complete cessation of corticosteroids. Method of measurement: History, physical examination, questionnaire , laboratory tests(ESR,CRP,CBC, Fecal calprotectin) , modified Mayo score. Clinical recurrence as having symptoms and a Mayo score greater than or equal to 3. Timepoint: Every 2 weeks from the start of tapering the dose of corticosteroids until 6 weeks after complete cessation of corticosteroids. Method of measurement: History, physical examination, questionnaire , laboratory tests(ESR,CRP,CBC, Fecal calprotectin) , modified Mayo score. Tabriz University of Medical Sciences Approved 2022-09-10 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)