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Studying the effect of Montelukast on patients with Irritable Bowel Syndrome

Evaluation of the efficacy of Montelukast in combination with Mebeverine and Mebeverine with placebo in patients with Irritable Bowel Syndrome

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160813029327N27
Enrollment
60
Registered
2025-03-15
Start date
2025-03-08
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Irritable bowel syndrome. Irritable bowel syndrome with diarrhea

Interventions

Intervention 1: Intervention group: In this group, patients will receive Montelukast 10 mg tablets produced by Abidi Pharmaceutical Company once a day for 4 weeks plus their standard treatment, which

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with diarrhea-predominant irritable bowel syndrome (IBS-D) based on the Rome IV criteria Age between 18-65 years old Informed consent

Exclusion criteria

Exclusion criteria: Patients with psychiatric disorders, kidney failure, celiac disease, and inflammatory bowel disease (IBD). People who suffer from depression. Pregnancy and lactation History of drug allergy

Design outcomes

Primary

MeasureTime frame
Abdominal Pain (Severity of pain and Duration of pain). Timepoint: Before intervention and 4 weeks after intervention and 8 weeks after intervention. Method of measurement: Irritable Bowel Severity Scale (IBSS).;Abdominal distension (Bloating, Swollen or Tight tummy). Timepoint: Before intervention and 4 weeks after intervention and 8 weeks after intervention. Method of measurement: Irritable Bowel Severity Scale (IBSS).;Satisfaction with fecal excretion. Timepoint: Before intervention and 4 weeks after intervention and 8 weeks after intervention. Method of measurement: Irritable Bowel Severity Scale (IBSS).;The impact of the IBS on the Patient's Quality of Life. Timepoint: Before intervention and 4 weeks after intervention and 8 weeks after intervention. Method of measurement: Irritable Bowel Severity Scale (IBSS).;Irritable Bowel Syndrome Severity Score. Timepoint: Before intervention and 4 weeks after intervention and 8 weeks after intervention. Method of measurement: Irritable Bowel Severity Scale (IBSS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Amirpasha Tabaeian

Iran University of Medical Sciences

aptabaeian@gmail.com+98 933 688 6433

Outcome results

None listed

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