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IRCT20120415009472N26 IRCT 2022-06-29 Iran University of Medical Sciences The effect of Portulaca Oleracea on ulcerative colitis The effect of Portulaca Oleracea supplement on inflammatory markers, antioxidant status and quality of life in patients with ulcerative colitis 2022-07-21 anticipated 100 Complete https://irct.ir/trial/64107 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: According to the sample size of 100 that has been determined, the randomization list is generated by a statistician in the form of random blocks in volume 4, taking into account 2 groups A and B (portulaca and placebo). Then, the Faculty of Pharmacy of the University of Tehran will do the packing according to the randomization list during the packing and will be assigned to the patients according to it. After performing the experiments and completing the study, a random list will be given to the researcher and the analysis will be performed. Until the end of the data analysis, the researcher, patient and analyst will not be informed of the type of drug and placebo and this issue will remain confidential. In case of deviation from the protocol, the analysis method will be used for treatment, Blinding description: Given that this study is a double-blind study, it means that the researcher, patient and analyst are not aware of the type of pill used (portulaca oleracea supplement or placebo). To do this, the relevant capsules are packed in similar packages with the same information and instructions and are coded as A and B by someone other than the interferer so that the interferer is not informed of the type of capsule received by each. The group is viewed. 2-3 Patients with ulcerative colitis. Intervention 1: Intervention group: For 8 weeks, they will receive two capsules of 500 mg of portulaca oleracea a day, with food, twice after breakfast and dinner, which are prepared by "Perpin Elixir Global" company. Intervention 2: Control group: For 8 weeks, they will receive two 500 mg maltodextrin capsule capsules a day, with food, twice after breakfast and dinner, which are prepared by Perpin Elixir Global. 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: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Researchers working in academic and scientific institutions Where to obtain: n-aryaeian@sina.tums.ac.ir rahimy.reihaneh97@gmail.com How to obtain: Document request email, applicant review, after confirmation, documents will be provided to the applicant. Comments:
public Dr. Nahid Aryaeian
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, Faculty of Health
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4734 n-aryaeian@sina.tums.ac.ir Iran University of Medical Sciences scientific Dr. Nahid Aryaeian
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, Faculty of Health
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4734 n-aryaeian@sina.tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) The patient has expressed his / her consent to participate in the study. Age 18 years and older Diagnosis of ulcerative colitis by a gastroenterologist and determination of the severity of the disease in mild to moderate stage Taking glucocorticosteroids BMI higher than 18.5 and less than 30 No pregnancy and lactation Do not take supplements (antioxidants, omega 3, etc.) in the last quarter (except for routine supplements prescribed for ulcerative colitis) No decision to become pregnant during the intervention Lack of other diseases and obvious intestinal disorders, known autoimmune diseases, cancer, inflammatory and infectious diseases No edema due to heart and kidney disease 18 years no limit Both Reluctance to continue cooperation No supplementation (patient acceptance and adaptation level is less than 80%). Recurrence of the disease in a way that leads to hospitalization of the patient Migration Changing the type and dose of the patient's drugs during the intervention Sudden onset of an acute illness (bacterial and viral infections, burns, heart attack, etc.) Taking anticoagulants such as warfarin or heparin Taking antihistamines and NSAIDs (ibuprofen, aspirin, diclofenac) Taking contraceptives During menstruation women Treatment - Drugs Placebo Intervention group: For 8 weeks, they will receive two capsules of 500 mg of portulaca oleracea a day, with food, twice after breakfast and dinner, which are prepared by "Perpin Elixir Global" company. Control group: For 8 weeks, they will receive two 500 mg maltodextrin capsule capsules a day, with food, twice after breakfast and dinner, which are prepared by Perpin Elixir Global. High-Sensitivity C-Reactive Protein (hs-CRP). Timepoint: Measurements at the beginning of the study (before the intervention) and 8 weeks after taking portulaca oleracea supplement. Method of measurement: It is calculated by calorimetric method and by autoanalyzer. enzyme-linked immunosorbent assay(ELISA). Total antioxidant capacity (TAC). Timepoint: Measurements at the beginning of the study (before the intervention) and 8 weeks after taking portulaca oleracea supplement. Method of measurement: chromatography. Erythrocyte sedimentation rate(ESR). Timepoint: Measurements at the beginning of the study (before the intervention) and 8 weeks after taking portulaca oleracea supplement. Method of measurement: Vacuum tube erythrocyte sedimentation rate. Superoxide dismutase(SOD). Timepoint: Measurements at the beginning of the study (before the intervention) and 8 weeks after taking portulaca oleracea supplement. Method of measurement: Spectrophotometry. Quality of Life. Timepoint: Measurements at the beginning of the study (before the intervention) and 8 weeks after taking portulaca oleracea supplement. Method of measurement: Questionnaire (IBDQ9). Body Mass Index(BMI). Timepoint: At the beginning of the study (before the intervention) and 8 weeks after starting portulaca oleracea supplement. Method of measurement: Weight in kg per square meter in height in meters. Waist circumference. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after starting portulaca oleracea supplement. Method of measurement: The shortest distance around the waist, below the chest and above the navel. Intensity of physical activity. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after starting portulaca oleracea supplement. Method of measurement: The amount of physical activity of individuals during the last 7 days in terms of metabolic equivalent. Iran University of Medical Sciences Approved 2022-05-09 Ethics committee of Iran University of Medical Sciences Tehran Hemmat Highway next to Milad Tower Tehran Tehran Iran (Islamic Republic of)