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IRCT20230315057731N1 IRCT 2023-05-12 Ahvaz University of Medical Sciences Resveratrol in multiple sclerosis Survey the effect of resveratrol supplementation on some oxidative stress and inflammatory biomarkers, fatigue scale, fasting blood sugar and lipid profile in patients with Multiple Sclerosis. 2023-04-21 anticipated 60 Complete https://irct.ir/trial/69227 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation of patients to each of the study groups will be done using random block method and using blocks of six. The blocks are designed by the statistical consultant and each block contains A or B, which represents the group receiving the drug or placebo. Patients receive the type of treatment (A or B) according to the order of entering the study and in the order specified by the randomization blocks. Unit codes are also applied in both packages containing medicine or placebo in advance, which means, for example, the first person who meets the study entry criteria, if based on the block, should receive medicine A, from the general box containing medicine A, one can It is randomly removed and given to the patient (the two-digit number on the can may be, for example, 15). The use of unit codes is based on the expert opinion of the statistics consultant and is used to prevent the breaking of A and B codes, Blinding description: In this study, the double-blind method will be used to reduce the possibility of information bias. In this way, both the patients and the researchers will be kept unaware of the type of treatment assigned to the subjects. For this purpose, resveratrol and placebo packages will be divided into A and B groups by someone outside the study. 3 Multiple Sclerosis. Intervention 1: Intervention group: 500 mg of resveratrol (in the form of two capsules made by Raha Company) for 8 weeks. Intervention 2: Control group: tow placebo per day (made by Raha company) for 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is The person's information will be confidential and the results will be as collective statistics
public Sara Keramatzadeh
Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan St., Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3571 5794 Sarakeramatzadeh@yahoo.com Ahvaz University of Medical Sciences scientific Marzie Zilaee
Department of Nutrition, School of Allied Medical Sciences, Jundishapur University of Medical Sciences, Golestan St., Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 2713 zilaee-m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) The disease is diagnosed according to McDonald's criteria. EDSS score 0 to 5 The clinical condition of the patient is relapse-remittance. Age 18 to 65 years 18 years 55 years Both The patient consumes alcohol, tobacco or drugs. Use of antioxidant supplements and hormonal treatments. Body mass index(BMI) higher than 30. Any progressive or autoimmune diseases. G35 Multiple sclerosis Treatment - Drugs Placebo Intervention group: 500 mg of resveratrol (in the form of two capsules made by Raha Company) for 8 weeks Control group: tow placebo per day (made by Raha company) for 8 weeks Tumor Necrosis Factor Alpha (TNF-α). Timepoint: Before and two months after intervention. Method of measurement: ELISA. MDA. Timepoint: Before and two months after intervention. Method of measurement: ELISA. Fatigue scale. Timepoint: Before and two months after intervention. Method of measurement: MFIS questionnaire. Fasting Blood Sugar. Timepoint: Before and two months after intervention. Method of measurement: Enzymatic. Lipid Profile (TC , TG, HDL, LDL). Timepoint: Before and two months after intervention. Method of measurement: Enzymatic. Ahvaz University of Medical Sciences Approved 2023-03-11 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz. Golestan Bolvar. Jundishapur University of Medical Sciences. Research Assistance Ahvaz Khouzestan Iran (Islamic Republic of)