Efficacy of Sertraline in Irritable Bowel Syndrome
Phase 4
Recruiting
- Conditions
- Irritable bowel syndrome.Irritable bowel syndrome
- Registration Number
- IRCT20150630022991N11
- Lead Sponsor
- Babol University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Adverse drug side effects. Timepoint: The fourth and eighth weeks after the intervention. Method of measurement: Medical visit.