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Efficacy of Sertraline in Irritable Bowel Syndrome

Efficacy of Sertraline on the Symptoms and Quality of Life in Irritable Bowel Syndrome Patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150630022991N11
Enrollment
60
Registered
2018-03-22
Start date
2018-01-05
Completion date
Unknown
Last updated
2018-03-26

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

Interventions

Intervention 1: Intervention group: Daily 50-200 milligram Sertraline manufactured in Doctor Abidi Pharmaceutical Company and 200 milligram Clofac for eight weeks. Intervention 2: Control group: Daily

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: The presence of ROME III diagnostic criteria for the diagnosis of irritable bowel syndrome Written consent for participation in the study

Exclusion criteria

Exclusion criteria: Age under 18 years Allergy to sertraline The presence of warning signs such as chronic fever, weight loss, gastrointestinal bleeding Pregnancy and breast feeding Use of any drug that affects the bowel function (such as laxatives, anti diarrhea and antibiotics) within one month before entering the study Known cases of lactose intolerance Comorbidity of other serious physical or psychological illnesses, serious suicidal thoughts and substance dependence that affect the treatment of patients and their compliance with the study protocol

Design outcomes

Primary

MeasureTime frame
Severity of irritable bowel syndrome symptoms. Timepoint: At baseline, and the fourth and eighth weeks after the intervention. Method of measurement: Visual Analogue Scale (VAS).;The patients quality of life. Timepoint: At baseline, and the eighth week after the intervention. Method of measurement: SF-36 quality of life questionnaire.

Secondary

MeasureTime frame
Adverse drug side effects. Timepoint: The fourth and eighth weeks after the intervention. Method of measurement: Medical visit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSussan Moudi, MD

Babol University of Medical Sciences

sussan.mouodi@gmail.com+98 11323268823

Outcome results

None listed

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