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IRCT2016042227520N1 IRCT 2016-05-29 Drug Applied Research Center The effects of oral nanocurcumin in Multiple Sclerosis patients The effects of oral nanocurcumin on expression levels of microRNAs and Treg cells and Th17 cells development factors in Multiple Sclerosis patients 2016-06-04 anticipated 50 Complete https://irct.ir/trial/22520 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Block randomization Blocking were used to balance the number of samples assigned to each study groups . The size of all blocks is equal and the blocks included 25 participants in the intervention group, who receive nanocurcumin capsules and 25 participants in the control group who receive placebo capsules, Blinding description: 1. Participant 2. Outcome assessor. 2-3 Multiple sclerosis. Intervention 1: The control group received placebo capsules once a day for six months. Intervention 2: Supplementation group received nanocurcumin capsules containing 80 mg nanocurcumin once a day for six months . Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mehdi Yousefi
Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 4665 Yousefime@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Mehdi Yousefi
Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 4665 Yousefime@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Willingness to cooperate; Ranging in age from 28 to 51 years MS diagnosis by neurologist patients in relapse and remitting EDSS<5/5 28 years 51 years Both Used nutritional supplements and antioxidants and alpha lipoic acid within a month before the study Pregnancy and lactation; History of diabetes and other chronic diseases; History of other autoimmune disease; corticosteroid use during illness; the occurrence of relapses during the study phase; acceptance rate of less than 70% of supplements; not wanting to continue cooperation. G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs The control group received placebo capsules once a day for six months. Supplementation group received nanocurcumin capsules containing 80 mg nanocurcumin once a day for six months . MiRNA-106b. Timepoint: Before interference and six months after interference. Method of measurement: Examined the expression levels of miRNA-106b by using Quantitative Real time PCR. MiRNA-25. Timepoint: Before interference and six months after interference. Method of measurement: Examined the expression levels of miRNA-25 by using Quantitative Real time PCR. MiRNA-326. Timepoint: Before interference and six months after interference. Method of measurement: Examined the expression levels of miRNA-326 by using Quantitative Real time PCR. The frequency of Treg cells. Timepoint: Before interference and six months after interference. Method of measurement: Examined the frequency of Treg cells by using flow cytometry. The frequency of Th17 cells. Timepoint: Before interference and six months after interference. Method of measurement: Examined the frequency of Th17 cells by using flow cytometry. Transcription factor: Foxp3. Timepoint: Before interference and six months after interference. Method of measurement: Examined the expression levels of Foxp3 by using Quantitative Real time PCR. Transcription factor: RoRγt. Timepoint: Before interference and six months after interference. Method of measurement: Examined the expression levels of RoRγt by using Quantitative Real time PCR. Cytokine: TGF-β. Timepoint: Before interference and six months after interference. Method of measurement: Examined the expression levels of TGF-β by using Quantitative Real time PCR. Cytokine: IL-17. Timepoint: Before interference and six months after interference. Method of measurement: Examined the expression levels of IL-17 by using Quantitative Real time PCR. Cytokine: TGF-β. Timepoint: Before interference and six months after interference. Method of measurement: Examined the amount of secreted cytokine TGF-β by using sandwich ELISA method. Cytokine: IL-17. Timepoint: Before interference and six months after interference. Method of measurement: Examined the amount of secreted cytokine IL-17 by using sandwich ELISA method. NCT03150966 ClinicalTrials.gov Drug Applied Research Center Approved 2016-03-07 Tabriz University of Medical Sciences Tabriz University of Medical Sciences , Golgasht Avenue, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)