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IRCT20190404043159N1 IRCT 2020-09-18 Esfahan University of Medical Sciences Duloxetine and the symptoms and quality of life of patients with irritable bowel syndrome The effect of duloxetine on symptoms and quality of life in patients with irritable bowel syndrome with moderate to severe symptoms 2020-10-15 anticipated 40 Complete https://irct.ir/trial/50982 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (eg, up or down) and the researcher's second default is to consider even numbers for intervention group . The researcher begins to read the numbers in a predetermined manner and the patients are divided, Blinding description: Patients are blinded according to the intervention or control treatment groups of the type of drug used. Also, the drugs are prepared in separate containers with numbering and the nurse who used the drug for the patients has no information about its type. Patients are seen by a specialist doctor and evaluated for symptoms and quality of life. Doctors and health evaluators are also unaware of the type of medication used. After collecting information, it enters the software with numbering, and after performing statistical analysis and completing the work, the codes are determined. Until then, the data analyzer and the data safety and monitoring committee do not know the patient groups. . 2-3 Condition 1: Irritable Bowel Syndrome. Condition 2: Quality of life. Condition 3: Stress, anxiety and depression. Intervention 1: Intervention group: Patients in this group will be treated with duloxetine daily at a target dose of 60 mg per day for three months. The severity of symptoms, quality of life and the level of stress, anxiety and depression of patients are measured by special questionnaires and by a gastroenterologist before and after the interventions and are compared with each other. Intervention 2: Control group: Patients in this group will be given placebo capsules daily for three months. The severity of symptoms, quality of life and the level of stress, anxiety and depression of patients are measured by special questionnaires and by a gastroenterologist before and after the interventions and are compared with each other. Yes - There is a plan to make this available What will be shared: All data can be shared after people have requested. When: Six months after publishing the results To whom: Academic researchers Conditions: Scientific uses Where to obtain: Isfahan University of Medical Sciences website How to obtain: Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data. Comments:
public Mohammad Reza Sharbafchi
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0042 sharbafchi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Reza Sharbafchi
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0042 sharbafchi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Men and women aged 18 to 65 years Diagnosis of irritable bowel syndrome by a gastroenterologist Moderate to severe symptoms Conscious consent to participate in the study Have a minimum literacy Absence of depressive disorders, bipolar disorder or psychotic disorders 18 years 65 years Both Diagnosis of any organic disease Failure to take medication regularly Failure to complete the questionnaire Severe side effects Patient request to leave the study K58 F43.0 Irritable bowel syndrome Acute stress reaction Treatment - Drugs Placebo Intervention group: Patients in this group will be treated with duloxetine daily at a target dose of 60 mg per day for three months. The severity of symptoms, quality of life and the level of stress, anxiety and depression of patients are measured by special questionnaires and by a gastroenterologist before and after the interventions and are compared with each other. Control group: Patients in this group will be given placebo capsules daily for three months. The severity of symptoms, quality of life and the level of stress, anxiety and depression of patients are measured by special questionnaires and by a gastroenterologist before and after the interventions and are compared with each other. Quality of life score. Timepoint: Before and one week after interventions. Method of measurement: Quality of Life Questionnaire for Patients with Irritable Bowel Syndrome. Anxiety, depression and stress score. Timepoint: Before and one week after interventions. Method of measurement: By The Depression, Anxiety, and Stress Scale – 21 (DASS-21) questionnaire. Severity of symptoms. Timepoint: Before and one week after interventions. Method of measurement: Irritable Bowel Syndrome Symptoms Severity Questionnaire. Esfahan University of Medical Sciences Approved 2017-05-28 Ethics committee of Isfahan University of Medical Sciences No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan Isfahan Isfehan Iran (Islamic Republic of)