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IRCT20091114002709N54 IRCT 2020-06-07 Iran University of Medical Sciences Ellagic acid in multiple sclerosis The effect of Ellagic acid on depression, inflammatory index (IFN-ƴ), oxidative (Nrf2) and nitrosative (NO) stress index, Brain Derived Neurotrophic Factor (BDNF), cortisol, serotonin and gene expression of indoleamine dioxygenase enzyme in patients with multiple sclerosis 2020-08-05 anticipated 46 Complete https://irct.ir/trial/48599 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method has been used for randomization. Blocks size of 4 are generated using www.sealedenvelope.com. In order to conceal the randomization process, individual codes have been on the medicine boxes, which are produced by the software, Blinding description: In order to apply concealment in the randomization process, individual codes will be used on the medicine boxes and the desired code will also be produced by the software. 3 Multiple sclerosis. Intervention 1: Intervention group: The intervention group receives two 90 mg allagic acid capsules daily for 12 weeks before lunch and dinner. Intervention 2: Control group: The placebo group takes two placebo capsules (containing cellulose) in the same color, shape, and odor as the ellagic acid supplement daily for 12 weeks before lunch and dinner. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Farzad Shidfar
Iran University of Medical Sciences, Shahid Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 86701 shidfar.f@iums.ac.ir Iran University of Medical Sciences scientific Farzad Shidfar
Iran University of Medical Sciences, Shahid Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 86701 farzadshidfar@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Willingness to cooperate Age range 18 to 55 years Depression according to Beck's questionnaire (score above 10) No change in the dose of antidepressant medication in the last three months Diagnosis of MS by a neurologist Patients are at recurrence and recovery EDSS <5.5 18 years 55 years Both Take nutritional, antioxidant, and ellagic acid supplements for a month before the study (except for routine supplements, which are part of the treatment plan for all patients, such as vitamin D) Pregnancy and lactation Drug abuse History of diabetes and other chronic diseases History of other autoimmune diseases Occurrence of recurrence of the disease during study Taking corticosteroids, estrogens, progesterone, immunosuppressants, diuretics during last month Dose changes and the type of medication used during study Change in physical activity Acceptance rate of less than 90% of supplementation Lack of willingness to cooperate G35 Multiple sclerosis Treatment - Other Placebo Intervention group: The intervention group receives two 90 mg allagic acid capsules daily for 12 weeks before lunch and dinner. Control group: The placebo group takes two placebo capsules (containing cellulose) in the same color, shape, and odor as the ellagic acid supplement daily for 12 weeks before lunch and dinner. IFN-ƴ. Timepoint: At the beginning and end of the intervention. Method of measurement: Laboratory kit. Depression score. Timepoint: The beginning and the end of the intervention. Method of measurement: Beck questionnaire. Nrf2. Timepoint: The beginning and end of the intervention. Method of measurement: Laboratory kit. NO. Timepoint: The beginning and end of the intervention. Method of measurement: Laboratory kit. BDNF. Timepoint: The beginning and the end of the intervention. Method of measurement: Laboratory kit. Cortisol. Timepoint: The beginning and the end of the intervention. Method of measurement: Laboratory kit. Serotonin. Timepoint: The beginning and the end of the intervention. Method of measurement: Laboratory kit. IDO gene expression. Timepoint: The beginning and end of the intervention. Method of measurement: Real Time RT-PCR. EDSS. Timepoint: The beginning and the end of the intervention. Method of measurement: EDSS QUESTIONNAIRE. Iran University of Medical Sciences Approved 2020-06-01 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)