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IRCT20190708044154N1 IRCT 2019-12-26 Tabriz University of Medical Sciences Effect of Bee Food Supplement Propolis on Food intake, Severity of disease and Quality of life in Patients with Irritable Bowel Syndrome (based on RomeIV criteria): a Randomized Double-Blind Clinical Trial Effect of Bee Food Supplement Propolis on Food intake, Severity of disease and Quality of life in Patients with Irritable Bowel Syndrome (based on RomeIV criteria): a Randomized Double-Blind Clinical Trial 2019-07-31 anticipated 52 Complete https://irct.ir/trial/40983 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Stratified block randomization, The type of blindness in our study will be double-blind. Prior to the onset of the study, the box containing the relevant pills is coded A and B by Pharmacist, in order to blind the researcher about which supplement each group received. In this study, the patients and researchers will not be aware of the allocation concealment until the end of the study, Blinding description: Except pharmacist, none of the participants and researchers will be aware of them until the end of the study. 2 Irritable Bowel Syndrome. Intervention 1: Intervention group: Propolis extract at a dose of 500 mg per day for six weeks, taking 2 tablets daily. Intervention 2: Control group: Placebo at a dose of 500 mg per day for six consecutive weeks. Yes - There is a plan to make this available What will be shared: The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles. When: The non-identifiable individual participant data will become available after the publication of the relevant articles. To whom: The non-identifiable individual participant data will become available to other researchers in academic institutions. Conditions: The data of the present study will only be accessible by other researchers, for conducting Meta analysis. Where to obtain: The researchers (student and her supervisor) How to obtain: Request a document via email Comments:
public Mahsa Miryan
Health and Nutrition Faculty, Attar Neishabouri Avenue, Golgasht street.
Tabriz Iran (Islamic Republic of) 5166614711 +98 937 608 4602 miryanm2014@gmail.com Tabriz University of Medical Sciences scientific Dr Alireza Ostadrahimi
Health and Nutrition Faculty, Attar Neishabouri Avenue, Golgasht Street.
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7584 ostadrahimi@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients diagnose irritable bowel syndrome with Rome IV criteria Filling out the written consent form Not having allergy to bee products 18 years 65 years Both Pregnant or lactating women Cases of malignancy or other chronic digestive diseases such as inflammatory bowel disease and celiac disease Regular use of drugs that modify gastrointestinal movements such as metoclopramide, cisapride, narcotics, diphenoxylate, etc. Regular use of laxatives History of major surgery in the digestive system (including Billroth's operating, having any Ostomy and resection of any part of the digestive tract). Following diet plans Individuals with daily and regular use of Prebiotic/ probiotic compounds Consumption antibiotics People who use psychotherapeutic drugs, including depression and anxiety. K58 Irritable bowel syndrome Treatment - Drugs Placebo Intervention group: Propolis extract at a dose of 500 mg per day for six weeks, taking 2 tablets daily. Control group: Placebo at a dose of 500 mg per day for six consecutive weeks. Severity of Irritable bowel syndrome. Timepoint: At the beginning of the study and the sixth week of the intervention. Method of measurement: IBS Severity Index(IBSSI). Quality of life in Patients with Irritable Bowel Syndrome. Timepoint: At the beginning of the study and the sixth week of the intervention. Method of measurement: Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QOL). Food intake in Patients with Irritable Bowel Syndrome. Timepoint: At the beginning of the study and the sixth week of the intervention. Method of measurement: 3-Day Food Intake Record. Tabriz University of Medical Sciences Approved 2019-07-28 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar Neishabouri Avenue, Golgasht Street. Tabriz East Azarbaijan Iran (Islamic Republic of)