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IRCT2017052927520N7 IRCT 2017-06-13 Connective Tissue Diseases Research Center Oral nanocurcumin and treatment of ankylosing spondylitis AS The effects of oral nanocurcumin on expression levels of microRNA and Th17 cells development factors in ankylosing spondylitis patients 2017-04-20 anticipated 24 Complete https://irct.ir/trial/22524 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 12 participants in the intervention group, who receive nanocurcumin capsules and 12 participants in the control group who receive placebo capsules, Blinding description: 1. Participant 2. Outcome assessor. 2-3 Ankylosing Spondylitis. Intervention 1: Supplementation group received nanocurcumin capsules containing 80 mg nanocurcumin once a day for four months. Intervention 2: The control group received placebo capsules once a day for four 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 28 to 51 years diagnosis of ankylosing spondylitis by rheumatologist patients with a BASDAI > 4 as having active disease disease duration 5-8 years 28 years 51 years Both Use of nutritional supplements and antioxidant and immunosuppressive drugs alpha-lipoic acid a month before the study pregnancy and lactation history of diabetes and other chronic diseases history of other autoimmune diseases acceptance rate of less than 70% of supplements not wanting to continue cooperation. M45 Ankylosing spondylitis Treatment - Drugs Placebo Supplementation group received nanocurcumin capsules containing 80 mg nanocurcumin once a day for four months The control group received placebo capsules once a day for four months. MiRNA-326. Timepoint: Before interference and four months after interference. Method of measurement: Examined the expression levels of miRNA-326 by using Quantitative Real time PCR. The frequency of Th17 cells. Timepoint: Before interference and four months after interference. Method of measurement: Examined the frequency of Th17 cells by using flow cytometry. Transcription factor: RoRγt. Timepoint: Before interference and four months after interference. Method of measurement: Examined the expression levels of RoRγt by using Quantitative Real time PCR. Cytokine: IL-17. Timepoint: Before interference and four months after interference. Method of measurement: Examined the expression levels of IL-17 by using Quantitative Real time PCR. Cytokine: IL-17. Timepoint: Before interference and four months after interference. Method of measurement: Examined the amount of secreted cytokine IL-17 by using sandwich ELISA method. Cellular and molecular changes in the immune system. Timepoint: after 4 months. Method of measurement: Flow cytometry, ELISA, RT-PCR. NCT03140657 CT.gov Connective Tissue Diseases Research Center Approved 2016-08-29 Connective Tissue Diseases Research Center 4rd floor, Connective Tissue Diseases Research Center,Imam Reza Hospital, Golgasht St, Tabriz, Iran TABRIZ East Azarbaijan Iran (Islamic Republic of)