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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20121212011738N3

Enrollment

160

Registered

2022-10-13

Start date

2022-10-12

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis. Ulcerative colitis

Interventions

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 week

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNezamdiba Mehran

Tabriz University of Medical Sciences

mndiba59@gmail.com+98 41 3347 8021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026