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IRCT20191105045340N2 IRCT 2023-07-09 Iran University of Medical Sciences The effect of bromelain in inflammatory bowel disease The effect of bromelain supplementation on disease activity and quality of life in patients with inflammatory bowel disease 2023-08-01 anticipated 84 Complete https://irct.ir/trial/70387 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients meeting the study's inclusion criteria will be allocated to group A or B according to a randomized list generated by the Random Number Calculator software, based on the order of their enrollment. Coordination will be established with Salamat Parmoun Amin pharmaceutical company for the preparation of the placebo. The drug manufacturer will be requested to assign one of the letters (A or B) to the drug and the other to the placebo using a coin toss for randomization, Blinding description: This interventional study will be conducted in a triple blind manner. Blinding includes patient, therapist and analyst. In order to make a placebo, coordination will be done with Salamat Parmon Amin production company and it is requested that the drug manufacturer put one of the letters A or B on the drug or placebo and the other letter on the other by using a lottery by throwing a coin. The confidentiality of both the drug and placebo types should be maintained until the conclusion of the data analysis, as a fundamental element of the research protocol, and after the analysis, the researcher will ask the person in charge of the drug manufacturing for the type of labels. This means that the therapist will not know the type of medicine or whether the medicine packages are placebo. Neither the patient nor the analyst will know about this. The placebo capsules will bear complete resemblance to the capsules of the intervention group in terms of their coating, color, and smell. 3 Condition 1: Crohn's disease. Condition 2: Ulcerative colitis. Intervention 1: Intervention group: They will receive 2 capsules of 500 (gdu) containing bromelain manufactured by Salamat Parmon Amin company for 8 weeks, 1 hour before or 2 hours after food. Intervention 2: Control group: They will receive 2 capsules of 500 mg containing maltodextrin made by Salamat Parmon Amin company for 8 weeks, 1 hour before or 2 hours after food. 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 There is no further information
public Seyedeh Tayebeh Rahideh
Department of Nutritional Sciences, Faculty of Health, Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4843 tayebeh_rahideh@yahoo.com Iran University of Medical Sciences scientific Seyedeh Tayebeh Rahideh
Iran University of Medical Sciences, Shahid Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4843 rahide.t@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of inflammatory bowel disease based on the diagnosis of a gastroenterologist Having mild to moderate disease activity in ulcerative colitis and mild to moderate disease activity in Crohn's Minimum age of 18 years and maximum of 70 years People express their satisfaction to participate in the study 18 years 70 years Both Smoking Alcohol consumption in the last 1 month Pregnancy and breastfeeding The consumption of antioxidant supplements such as Vitamin C, Vitamin E, Selenium, Curcumin, Pomegranate Peel, or any other antioxidant supplements in the last 1 month The consumption of anticoagulant drugs The consumption of drugs against tumor necrosis factor alpha The consumption of steroidal and non-steroidal anti-inflammatory agents, antibiotics, fiber, probiotic during the two weeks before the intervention. Patients in the stage of Vitamin D deficiency. Suffering from other chronic inflammatory diseases, mental disorders, or neurological diseases (such as Parkinson's, Alzheimer's, intracranial hemorrhage, head or brain injury), Cushing's syndrome, polycystic ovary syndrome, anemia, hemophilia, leukopenia, thrombocytopenia, asthma, cancer, anorexia nervosa, bulimia nervosa, other autoimmune diseases, and major gastrointestinal surgeries that may affect the condition under study. K50 K51 Crohn's disease [regional enteritis] Ulcerative colitis Treatment - Other Treatment - Other Intervention group: They will receive 2 capsules of 500 (gdu) containing bromelain manufactured by Salamat Parmon Amin company for 8 weeks, 1 hour before or 2 hours after food. Control group: They will receive 2 capsules of 500 mg containing maltodextrin made by Salamat Parmon Amin company for 8 weeks, 1 hour before or 2 hours after food. Ulcerative colitis disease activity questionnaire score. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Ulcerative Colitis disease Activity Evaluation Questionnaire. Crohn disease activity questionnaire score. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Crohn disease Activity Evaluation Questionnaire. Quality of life questionnaire score in inflammatory bowel disease. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Quality of life assessment questionnaire in inflammatory bowel disease. Iran University of Medical Sciences Approved 2023-05-23 Ethics committee of Iran University of Medical Sciences Management of Research Development and Evaluation, Deputy of research and technology, next to Milad Tower, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)