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IRCT20120415009472N28 IRCT 2023-09-05 Iran University of Medical Sciences The effect of grape seed extract in ulcerative colitis The effect of grape seed extract on the expression of genes mediating immunity, inflammation, disease severity and quality of life in patients with ulcerative colitis 2023-10-07 anticipated 66 Complete https://irct.ir/trial/72339 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: A person outside the study is asked to randomly assign the letter A or B to the cans of supplement and placebo by flipping a coin, and then hand the cans to the researcher. It is used to randomize patients to receive packages A and B using random number generation software.After analyzing the data, the person outside the study will be requested to provide the names of the drug and placebo labels to be utilized in the results and discussion section, Blinding description: Supplement and placebo will be categorized based on random codes. The researcher, gastroenterologist, individuals involved in sample evaluation, and the person conducting statistical analysis will be blinded to the intervention or control group assignment. 3 Patients with ulcerative colitis. Intervention 1: Intervention group: Patients will receive 600 mg/day (two tablets of 300 mg) of grape seed extract, which will be prepared by Barij Essan Pharmaceutical Company, for a duration of 12 weeks. Intervention 2: Control group:Patients will receive 600 mg/day (two tablets of 300 mg) of placebo, which will be prepared by Barij Essan Pharmaceutical Company, for a duration of 12 weeks. Yes - There is a plan to make this available What will be shared: Unidentifiable personal data of participants; Only part of the data such as the original outcome information When: The access period starts 6 months after the results are published To whom: Only for researchers working in academic and scientific institutions Conditions: To conduct studies Where to obtain: Dr. Nahid Aryaeian : aryaeian.n@iums.ac.ir How to obtain: Request by e-mail along with providing a complete explanation of why the data is needed Comments:
public Dr. Nahid Aryaeian
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, , School of Public Health
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4734 aryaeian.n@iums.ac.ir Iran University of Medical Sciences scientific Dr. Nahid Aryaeian
University of Medical Sciences, next to Milad Tower, Hammet Highway, Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4734 aryaeian.n@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) BMI of patients between 18.5-35 kg/m2 Diagnosis of ulcerative colitis in the mild to moderate stage by a gastroenterologist based on patient tests, patient symptoms (disease severity questionnaire)and colonoscopy. Patients using one of the drug groups (5-aminosalicylic acid (Petasa, Mesalazine or Asacol). 18 years 65 years Both Pregnancy and breastfeeding Taking anticoagulants such as warfarin or heparin Suffering from other intestinal diseases, autoimmune diseases, cancer, inflammatory diseases, and infectious diseases. K51 Ulcerative colitis Treatment - Drugs Placebo Intervention group: Patients will receive 600 mg/day (two tablets of 300 mg) of grape seed extract, which will be prepared by Barij Essan Pharmaceutical Company, for a duration of 12 weeks. Control group:Patients will receive 600 mg/day (two tablets of 300 mg) of placebo, which will be prepared by Barij Essan Pharmaceutical Company, for a duration of 12 weeks. T-bet gene expression. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Real-time PCR. GATA3 gene expression. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Real-time PCR. ROR-ꝩtgene expression. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Real-time PCR. FOXp3 gene expression. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Real-time PCR. Serum concentration of hs-CRP. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Eliza. Serum concentration of IL-17. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Eliza. ESR. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: westergren. Disease Severity(SCCAI-Q). Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Severity of Disease Questionnaire (SCCAI-Q). Quality of Life(IBDQ-9). Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Quality of life questionnaire(IBDQ-9). Total Antioxidant Capacity. Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: TAC concentration in serum using an ELISA kit. Malondialdehyde (MDA). Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: MDA concentration in serum using an ELISA kit. Superoxide dismutase (SOD). Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: SOD concentration in serum using an ELISA kit. Glutathione peroxidase (GPX). Timepoint: At the beginning of the study and at the end of week 12. Method of measurement: GPX concentration in serum using an ELISA kit. BMI. Timepoint: At the beginning of the study and the twelfth week. Method of measurement: Weight(kg)/ (height)m². Iran University of Medical Sciences Approved 2023-08-09 Ethics committee of Iran University of Medical Sciences Research and Technology Vice-Chancellor, Central Headquarters Building, Iran University of Medical Sciences, next to Milad Tower, Hammet Highway, Tehran Tehran Tehran Iran (Islamic Republic of)