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IRCT20120415009472N22 IRCT 2020-12-19 Iran University of Medical Sciences Ellagic acid in multiple sclerosis Effect of Ellagic acid supplementation on disease severity, expression of involved genes in pathogenesis, and levels of immunity and inflammatory biomarkers in patients with Multiple Sclerosis 2021-01-10 anticipated 46 Complete https://irct.ir/trial/53020 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation will be done with the balanced block method and 4 blocks will be used. Assuming having two groups A and B, by random permutation method, we will have these block modeling: AABB, ABAB, ABBA, BAAB, BBAA, BABA, in which subjects will be placed in these blocks in order of entering in the study and each patient randomly will be assigned in the intervention or control groups, Blinding description: The method of blinding is that the statistical consultant encodes the supplements from 1 to 46 and the researcher, without knowing the type of supplement or placebo, will present the supplements to the subjects from the beginning of the study. 3 Multiple Sclerosis. Intervention 1: Intervention group: Intervention group: The intervention group receives two 90 mg capsules of ellagic acid daily for 12 weeks before lunch and dinner (made by Exir Gostar Company). Intervention 2: Control group: The placebo group receives two placebo capsules (containing cellulose) in the same color, shape and smell as the ellagic acid supplement daily for 12 weeks before lunch and dinner (made by Exir Gostar). Yes - There is a plan to make this available What will be shared: Information on primary and secondary outcomes can be shared at the end of the study. When: 6 months after the publication of the article To whom: All individuals, including researchers who work in university and scientific places, physicians, nutritionists and those engaged in the industry, can use these documentations. Conditions: Use of the documentation is permitted if there is no copyng and no citation or inappropriate citation. Where to obtain: Dr. Naheed Aryaeian How to obtain: Applicants will be able to access the data from the present study by sending an email to the corresponding author within a maximum of one week. Comments:
public Dr. Naheed Aryaeian
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4750 nah_arya2002@yahoo.com Iran University of Medical Sciences scientific Naheed Aryaeian
Nutrition department, school of public health, Hemmat broad way
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4750 n-aryaeian@sina.tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patient informed consent Disease diagnosis based on McDonald's criteria and MRI by a neurologist EDSS score less than 5.5 Relapsing-remitting status of the disease age between 18 and 55 years 18 years 55 years Both Reluctance to participate in the study Take nutritional supplements, antioxidants, and ellagic acid during a month before the start of the study and during the study (except for routine supplements that are part of the treatment plan for all patients, including vitamin D) Taking nonsteroidal anti-inflammatory drugs, estrogen, progesterone, immunosuppressives, diuretics, and corticosteroids during a month before the study Patients with inflammatory bowel disease (IBD), rheumatoid arthritis, systemic lupus erythematosus, type 1 diabetes, and other autoimmune diseases are excluded from the study. Pregnancy and lactation Drug abuse G35 Multiple sclerosis Treatment - Other Placebo Intervention group: Intervention group: The intervention group receives two 90 mg capsules of ellagic acid daily for 12 weeks before lunch and dinner (made by Exir Gostar Company). Control group: The placebo group receives two placebo capsules (containing cellulose) in the same color, shape and smell as the ellagic acid supplement daily for 12 weeks before lunch and dinner (made by Exir Gostar). Expanded Disability Status Scale. Timepoint: At the beginning of the study and 12 weeks after supplementation with ellagic acid. Method of measurement: Extensive Disability Scale Questionnaire. Interleukin 17. Timepoint: At the beginning of the study and 12 weeks after supplementation with ellagic acid. Method of measurement: Interleukin 17 kit by ELISA method. Interleukin 4. Timepoint: At the beginning of the study and 12 weeks after supplementation with ellagic acid. Method of measurement: Interleukin 4 kit by ELISA method. Transforming growth factor beta (TGF-β). Timepoint: At the beginning of the study and 12 weeks after supplementation with ellagic acid. Method of measurement: TGF-β kit by ELISA method. Interferon gamma. Timepoint: At the beginning of the study and 12 weeks after supplementation with ellagic acid. Method of measurement: Interferon gamma kit by ELISA method. T-bet gene expression. Timepoint: At the beginning of the study and 12 weeks after supplementation with ellagic acid. Method of measurement: Standard quantitative real - time PCR. GATA3 gene expression. Timepoint: At the beginning of the study and 12 weeks after supplementation with ellagic acid. Method of measurement: Standard quantitative real - time PCR. RORγt gene expression. Timepoint: At the beginning of the study and 12 weeks after supplementation with ellagic acid. Method of measurement: Standard quantitative real - time PCR. Iran University of Medical Sciences Approved 2020-12-13 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway, next to Milad tower. Tehran Tehran Iran (Islamic Republic of)