IRCT20150630022991N11 IRCT 2018-03-22 Babol University of Medical Sciences Efficacy of Sertraline in Irritable Bowel Syndrome Efficacy of Sertraline on the Symptoms and Quality of Life in Irritable Bowel Syndrome Patients 2018-01-05 anticipated 60 Complete https://irct.ir/trial/30215 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random allocation. 4 Irritable bowel syndrome. 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 200 milligram Clofac for eight weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It will be decided depending on the instructions of the selected journal for publication of the final manuscript.

public Sussan Moudi, MD

Department of Psychiatry, Shahid Yahyanejad Hospital, Babol

Babol Iran (Islamic Republic of) 4718747415 +98 11323268823 sussan.mouodi@gmail.com Babol University of Medical Sciences scientific Sussan Moudi

Department of Psychiatry, Shahid Yahyanejad Hospital, Babol

Babol Iran (Islamic Republic of) 4718747415 +98 11323268823 sussan.mouodi@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) The presence of ROME III diagnostic criteria for the diagnosis of irritable bowel syndrome Written consent for participation in the study 18 years no limit Both 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 K58 Irritable bowel syndrome Treatment - Drugs Treatment - Drugs Intervention group: Daily 50-200 milligram Sertraline manufactured in Doctor Abidi Pharmaceutical Company and 200 milligram Clofac for eight weeks Control group: Daily 200 milligram Clofac for eight weeks 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. Adverse drug side effects. Timepoint: The fourth and eighth weeks after the intervention. Method of measurement: Medical visit. Babol University of Medical Sciences Approved 2017-08-27 Ethics Committee of Babol University of Medical Sciences Ganjafrooz Avenue, Babol Babol Mazandaran Iran (Islamic Republic of)