]>
IRCT2017100213739N10 IRCT 2017-11-02 Vice-Chancellor for Research, Tehran University of Medical Sciences Evaluation of the therapeutic efficacy of Mannuronic Acid in Rheumatoid Arthritis Comparing the effects of β-D-Mannuronic acid with Placebo on disease activity and inflammatory markers in patients with Rheumatoid Arthritis 2017-10-16 anticipated 203 Complete https://irct.ir/trial/13525 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In order to allocate the patients randomly into two groups of treatment and control, at first 29 blocks of 7 with C and T letters (The letters indicate the intervention and control groups) are created in each 4 patients are belonged to the intervention group and 3 patients are belonged to the control group). Then the blocks are randomly selected and arranged to obtain a sequential combination of 203 letters. Each letter will be placed in a sealed packet according to the obtained sequence. 3 Rheumatoid Arthritis. Intervention 1: The Treatment group will receive β-D-Mannuronic acid 1500 mg/day (three oral 500 mg tablets/day) which is produced from the decomposition of Alginate powder (a safe and natural substance used in food and pharmaceutical industries) for 12 weeks. It should be mentioned that Alginate powder is purchased from Sigma Corporation of U.S.A and β-D-Mannuronic acid is produced from it's decomposition in central laboratory of immunology department at School of Public Health and Institute of Health Research affiliated by Tehran University of Medical Sciences. Intervention 2: The control group will receive orally 1500 mg/day (three 500 mg tablets/day) of plcebo for 12 weeks.
public Dr. Abbas Mirshafiey
Department of Immunology, School of Public Health, Tehran University of Medical Sciences,16 Azar St ,Enghelab Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) - +98 21 8895 4913 mirshafiey@tums.ac.ir Department of pathobiology, School of Public Health, Tehran University of Medical Sciences scientific Dr. Abbas Mirshafiey
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences,16 Azar St ,Enghelab Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) - +98 21 8895 4913 mirshafiey@tums.ac.ir Department of pathobiology, School of Public Health, Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Pakistan Inclusion Criteria: 1.Patients should be 18-65 year old, afflicted by Rheumatoid Arthritis, diagnosed based on the American College of Rheumatology (ACR) Diagnostic Criteria by a rheumatology specialist after evaluating the clinical parameters such as ESR, RF, CRP and Anti-CCP. 2.Each patient must sign written informed consent. 3.The disease in all patients should be in active form (DAS28>2.6) 4.None of patients must suffer from another concomitant diseases like Hepatic, renal, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral diseases. Exclusion Criteria: 1.History of fever and Infectious diseases, positive pregnancy test or lactation, other collagen- vascular diseases, other auto-immune diseases and Malignancies. 2.Enrolling in another clinical trial study within last 4 weeks 3.Suffering from other concomitant diseases such as hepatic, renal, hematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease. 18 years 65 years Both M05 Seropositive Rheumatoid Arthritis Treatment - Drugs Treatment - Drugs The Treatment group will receive β-D-Mannuronic acid 1500 mg/day (three oral 500 mg tablets/day) which is produced from the decomposition of Alginate powder (a safe and natural substance used in food and pharmaceutical industries) for 12 weeks. It should be mentioned that Alginate powder is purchased from Sigma Corporation of U.S.A and β-D-Mannuronic acid is produced from it's decomposition in central laboratory of immunology department at School of Public Health and Institute of Health Research affiliated by Tehran University of Medical Sciences. The control group will receive orally 1500 mg/day (three 500 mg tablets/day) of plcebo for 12 weeks. Morning stiffness. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire. The number of swollen joints. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Examination. Pain. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Examination. Severity of disease. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire. Serum level of CRP. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Turbidometry. Level of ٍُESR. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: See through Westergren method. Anti-cyclic Citrullinated Peptide (anti-CCP) Antibodies. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: ELISA. Rheumatoid factor (RF). Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: See through Agglutination. Vice-Chancellor for Research, Tehran University of Medical Sciences Approved 2017-09-06 Ethics committee of Mashhad University of Medical Sciences Mashhad University of Medical Sciences-Mashhad-Iran Mashhad Iran (Islamic Republic of)