Effect of sertraline and nortriptyline on irritable bowel syndrome: A randomized clinical trail

Phase 3

Conditions: irritable bowel syndrome.
Irritable bowel syndrome

Registration Number: IRCT201504131647N3

Lead Sponsor: Vice Chancellor for research; Shahroud University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 30

Inclusion Criteria

presence of clinical findings of irritable bowel syndrome according to ROME II criteria; including abdominal pain or refferal pain at least 3 days in every months.

Exclusion criteria: use of analgesic drugs; pregnant women; breast feeding; patients with major depressive disorder (MDD) according to DSM-IV-TR; gastrointestinal bleeding; presence of any finding in favor of organic disorders in the lab tests; or organic disorder in colonoscopy of high risk patients.

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity abdominal pain. Timepoint: prior to intervention and 8 weeks after intervention. Method of measurement: Questionnaire (IBS, Symptom Severity Scoring) and visual scale of pain.;Severity of abdominal distension. Timepoint: prior to intervention and 8 weeks after intervention. Method of measurement: Questionnaire (IBS, Symptom Severity Scoring) and visual scale of pain.;Frequency of abdominal pain. Timepoint: prior to intervention and 8 weeks after intervention. Method of measurement: Questionnaire (IBS, Symptom Severity Scoring) and visual scale of pain.;Dissatisfaction with bowel habits. Timepoint: prior to intervention and 8 weeks after intervention. Method of measurement: Questionnaire (IBS, Symptom Severity Scoring) and visual scale of pain.;Interference with quality of life. Timepoint: prior to intervention and 8 weeks after intervention. Method of measurement: Questionnaire (IBS, Symptom Severity Scoring).

Secondary Outcome Measures