The effect of Montelukast in reducing disease recurrence in patients with ulcerative colitis

Phase 3

Recruiting

• Conditions: lcerative colitis.; Ulcerative colitis

• Registration Number: IRCT20121212011738N3
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.