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IRCT20091114002709N60 IRCT 2023-07-01 Iran University of Medical Sciences Investigating the effect of pomegranate peel supplement in ulcerative colitis The effect of pomegranate peel supplementation on the serum levels of IL-6, IL-10, disease activity index and quality of life in patients with mild to moderate ulcerative colitis: a double-blind clinical trial. 2023-06-25 anticipated 80 Complete https://irct.ir/trial/69853 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study uses the random allocation method, blocks, to avoid selection bias. For this purpose, the Randomization.com website is used to create blocks. Then, according to the generated sequence, 40 patients were placed in the intervention group and 40 patients in the comparison group, Blinding description: Codes 1 to 80 will be prepared by the statistical consultant and stuck on the supplementary packages and their envelopes. Medicine will be placed in closed paper envelopes along with 3 questionnaires as a 24-hour reminder. The doctor, researcher, individual people, and the person who provides the envelopes to the patients are unaware of the type of treatment and only the consultants of the statistical plan know about the codes. At the beginning of the case study, after blood sampling, envelopes are received in the order of numbers and the responsible person writes down the received code and the patient's name. The order of diagnosis of patients for blinding will be provided to statistical consultants until the end of the study, and other people will be unaware of the plan. 2-3 Inflammatory bowel disease, ulcerative colitis. Intervention 1: Intervention group: The group receiving the supplement of 500 mg of dry pomegranate peel extract for eight weeks. In this study, the supplements of Adib Elixir herbal products company with health approval (8975464292723001 IRC: ) are used. Pomegranate peel dry extract is produced by this company in capsule cover and 500 mg content. Intervention 2: Control group: The group receiving 500 mg placebo supplement for eight weeks. Placebo capsules are also prepared from Adib Elixir company. These capsules contain 500 mg of medicated corn starch. No - There is not a plan to make this available Justification or reason for not sharing IPD is According to the additional protocol, the personal information of the candidates is considered confidential.
public Farzad Shidfar
School of Health, Iran University of Medical Sciences, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8862 2755 shidfar.f@iums.ac.ir Iran University of Medical Sciences scientific Farzad Shidfar
School of Health, Iran University of Medical Sciences, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8862 2755 shidfar.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 1. Patient consent to participate in the study 2. Aged 18 years or older (age ≤ 18 years) 3. BMI above 18.5 and less than 30 kg/m2 (30 ≤ BMI ≤ 18.5) 4. Diagnosis of ulcerative colitis by a specialist 5. People with mild to moderate ulcerative colitis according to specialist diagnosis and the Partial Mayo scoring index 6. Users of oral drugs of the 5-aminosalicylic acid group (pentasa, mesalazine or asacol, sulfasalazine) as well as immunomodulatory drugs (azathioprine, methotrexate, prograf, selpest or 6-mercaptopurine). 18 years no limit Both 1. Changing the type and dosage of the drug used during the last month 2. Pregnant or lactating women 3. Suffering from other diseases, including digestive diseases, autoimmune diseases, cancer, inflammatory and infectious diseases 4. Use of multivitamin-mineral, omega-3, polyphenolic, antioxidants, and herbal supplements during the past month (except for commonly prescribed supplements in ulcerative colitis) 5. Use of corticosteroids, NSAIDs (profen, aspirin and diclofenac), and anti-TNF drugs (Cinnora or Adalimumab, Infliximab or Remicade) K51 Ulcerative colitis Treatment - Drugs Treatment - Drugs Intervention group: The group receiving the supplement of 500 mg of dry pomegranate peel extract for eight weeks. In this study, the supplements of Adib Elixir herbal products company with health approval (8975464292723001 IRC: ) are used. Pomegranate peel dry extract is produced by this company in capsule cover and 500 mg content. Control group: The group receiving 500 mg placebo supplement for eight weeks. Placebo capsules are also prepared from Adib Elixir company. These capsules contain 500 mg of medicated corn starch. Interleukin 6. Timepoint: ََAt the beginning (before starting the intervention ) and the end of the study (after the end of the eighth week). Method of measurement: Blood test. Interleukin 10. Timepoint: At the beginning (before starting the intervention ) and the end of the study (after the end of the eighth week). Method of measurement: Blood test. Disease activity index. Timepoint: At the beginning (before starting the intervention ) and the end of the study (after the end of the eighth week). Method of measurement: Disease activity index questionnaire. Quality of life. Timepoint: At the beginning (before starting the intervention ) and the end of the study (after the end of the eighth week). Method of measurement: IBD quality of life questionnaire. Blood pressure. Timepoint: At the beginning (before starting the intervention ) and the end of the study (after the end of the eighth week). Method of measurement: Upper arm blood pressure digital monitor. Iran University of Medical Sciences Approved 2023-06-25 Ethics committees of Iran university of medical scinces Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Shahid Hemmat Highway, 1449614535, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)