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IRCT138805012159N2 IRCT 2010-05-29 Isfahan University of Medical Sciences Evaluating the effect of Fluoxetine on symptoms and quality of life of patients with moderate to severe irritable bowel syndrome in adults. Evaluating the effect of Fluoxetine on symptoms and quality of life of patients with moderate to sever irritable bowel syndrome in adults. 2010-06-22 anticipated 180 Complete https://irct.ir/trial/1778 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 Irritable bowel syndrome. Intervention 1: Fluoxetine 20 milligram, capsule, daily plus placebo capsule, oral, daily for 12 weeks. Intervention 2: 2 placebo capsules, oral, daily for 12 weeks. Intervention 3: Fluoxetine, 40 milligram, 20 miligram capsules twice daily, oral, for 12 weeks.
public Forugh Ghaedi
Isfahan University of Medical Sciences- Azadi square- Isfahan
Isfahan Iran (Islamic Republic of) +98 31 1668 5149 f_ghaedi@edc.mui.ac.ir Isfahan University of Medical Sciences scientific Ali Gholamrezaei
Isfahan University of Medical Sciences -Azadi square-Isfahan
Isfahan Iran (Islamic Republic of) +98 31 1668 5149 gholamrezaei@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: age 18-65 years, IBS diagnosis through ROME II criteria, moderate to severe symptoms through severity of symptom questionnaire Exclusion criteria : Diagnosis of any organic disease related to symptoms during the study, psychological disorders Taking any other psychotropic drugs at the beginning or during the trial or taking a MAO-inhibitor drugs during 2 weeks before entering to the trial, record of taking Fluoxetine for treatment of IBS in the past, Presence of any contraindications for taking Fluoxetine, low compliance, severe complications due to Fluoxetine, Pregnancy or breastfeeding at the beginning or during the trial 18 years 65 years Both K58 Irritable bowel syndrome Treatment - Drugs Placebo Treatment - Drugs Fluoxetine 20 milligram, capsule, daily plus placebo capsule, oral, daily for 12 weeks 2 placebo capsules, oral, daily for 12 weeks Fluoxetine, 40 milligram, 20 miligram capsules twice daily, oral, for 12 weeks Severity of symptom. Timepoint: Baseline - end of the 4th and 12th week of the intervention and 3 and 6 month after the end of the study. Method of measurement: IBS-SSS questionnaire. Quality of life. Timepoint: baseline, end of the 4th and 12th week of the intervention and 3 and 6 month after the end of the study. Method of measurement: IBS quality of life questionnaire (IBS-QOL). Depression. Timepoint: Baseline - end of the 4th and 12th week of the intervention and 3 and 6 month after the end of the study. Method of measurement: Hospital anxiety and Depression questionnaire. Anxiety. Timepoint: Baseline - end of the 4th and 12th week of the intervention and 3 and 6 month after the end of the study. Method of measurement: Hospital anxiety and Depression questionnaire. Isfahan University of Medical Sciences Approved 2010-04-25 Isfahan Isfahan University of Medical Sciences - Azadi square - Isfahan Isfahan Iran (Islamic Republic of)