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IRCT20160422027520N12 IRCT 2019-05-09 Connective Tissue Diseases Research Center Effect of oral nanocurcumin in patients with Behcet's disease. Effect of oral nanocurcumin on disease activity, expression levels of microRNA and Th17 cells and Treg cells development factors and serum IL-17, IL-10 level in Behcet patients 2019-06-10 anticipated 36 Complete https://irct.ir/trial/39339 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Other design features: -, Randomization description: From among the patients who volunteer to participate in the study, 36 individuals will be selected by simple randomization. Randomization method: Blocking Randomization unit: individual stratification: age and sex Randomization tool: Random allocation software Method of random sequence generation: Random allocation software Allocation concealment: The generated random sequence will be kept in a protected location and administered by an independent party who is not involved in the trial throughout the study. Due to proper allocation concealment, trial investigators and participants will be unaware of upcoming allocations, Blinding description: This is a double blind study in which the researcher and patients who participate in study will be blinded to the group assignments. The patients will receive the supplements by another person who is not involved in doing the assessment and chemical analysis. Patients will be informed about the type of supplements (nanocurcumin and placebo) however they will not be aware about the group assignments. Placebo capsules are identical to nanocurcumin supplements in shape and color and size. N/A Behcet's disease. Intervention 1: Intervention group: nanocurcumin Patients in intervention group will take one 80 mg nanocurcumin capsule (produced by Exir Nanosina pharmaceutical company) with their lunch meal per day over a period of 2 months. Intervention 2: Control group: Placebo Patients in control group will take one placebo capsule (produced by Exir Nanosina pharmaceutical company) with their lunch meal per day over a period of 2 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, Iran
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3336 4665 yousefime@tbzmed.ac.ir Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran scientific Mehdi Yousefi
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3336 4665 yousefime@tbzmed.ac.ir Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran Iran (Islamic Republic of) Willingness to cooperate Age range 20 to 60 years Diagnosis of Behcet's disease by rheumatologist 20 years 60 years Both Use of nutritional supplements and antioxidant and alpha-lipoic acid during a month before the study Pregnancy and lactation History of diabetes and other chronic diseases The history of other autoimmune diseases Admission rate less than 70% of supplemental intake Smoking M35.2 Behcet's disease Treatment - Other Placebo Intervention group: nanocurcumin Patients in intervention group will take one 80 mg nanocurcumin capsule (produced by Exir Nanosina pharmaceutical company) with their lunch meal per day over a period of 2 months. Control group: Placebo Patients in control group will take one placebo capsule (produced by Exir Nanosina pharmaceutical company) with their lunch meal per day over a period of 2 months. The expression of miRNAs. Timepoint: Before and after intervention. Method of measurement: QRT-PCR. Frequency of Th17 cells. Timepoint: Before and after intervention. Method of measurement: Flow cytometry. The expression of the RoRĪ³. Timepoint: Before and after intervention. Method of measurement: QRT-PCR. IL-23 and IL-17 cytokine gene expression. Timepoint: Before and after intervention. Method of measurement: QRT-PCR. The level of IL-23 and IL-17 cytokine secretion. Timepoint: Before and after intervention. Method of measurement: Elisa. Frequency of Treg cells. Timepoint: Before and after intervention. Method of measurement: Flow cytometry. The expression of the Foxp3. Timepoint: Before and after intervention. Method of measurement: QRT-PCR. TGF-b and IL-10 cytokine gene expression. Timepoint: Before and after intervention. Method of measurement: QRT-PCR. The level of TGF-b and IL-10 cytokine secretion. Timepoint: Before and after intervention. Method of measurement: Elisa. Connective Tissue Diseases Research Center Approved 2019-04-08 Ethics committee of Tabriz University of Medical Sciences GOLGASHT, University Avenue,Tabriz University of Medical Sciences, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)