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IRCT2016092813739N5 IRCT 2016-10-30 Vice-Chancellor for Research, Tehran University of Medical Sciences The therapeutic effects of α-L-Guluronic acid in patients with Rheumatoid Arthritis Comparing the effects of α-L-Guluronic acid with conventional Non-steroidal anti-inflammatory drugs on disease activity and inflammatory markers in patients with Rheumatoid Arthritis 2016-11-05 anticipated 36 Complete https://irct.ir/trial/13520 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 6 blocks of 6 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 2 patients are belonged to the control group). Then the blocks are randomly selected and arranged to obtain a sequential combination of 36 letters. Each letter will be placed in a sealed packet according to the obtained sequence. 1-2 Rheumatoid Arthritis. Intervention 1: The intervention group will receive 1500 mg/day (three 500 mg tablets/day) of α-L-Guluronic acid orally for 12 weeks. The α-L-guluronic acid produced from the decomposition of Alginate powder (a safe, natural substance used in food and pharmaceutical industries) purchased from Sigma Corporation of U.S.A, in central laboratory of immunology department of School of Public Health and Institute of Health Research of Tehran University of Medical Sciences. Intervention 2: Control group will receive 1500 mg/day (three 500 mg tablets/day) of plcebo orally for 12 weeks.
public 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 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) Inclusion Criteria: 25-60 years old patients, Diagnosed with RA according to American College of Rheumatology Diagnostic Criteria after the initial visit by a specialist in rheumatology and parameters ESR, RF, CRP and Anti-CCP elected, Each patient must sign written informed consent. Exclusion Criteria: History of fever and Infectious diseases, Positive pregnancy test or Lactation, Other collagen- vascular diseases, Other auto-immune diseases, Malignancies, Patients have enrolled another clinical trial study within last 4 weeks, Other concomitant diseases (Hepatic, renal, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease). 25 years 60 years Both M05 Seropositive Rheumatoid Arthritis Treatment - Drugs Treatment - Drugs The intervention group will receive 1500 mg/day (three 500 mg tablets/day) of α-L-Guluronic acid orally for 12 weeks. The α-L-guluronic acid produced from the decomposition of Alginate powder (a safe, natural substance used in food and pharmaceutical industries) purchased from Sigma Corporation of U.S.A, in central laboratory of immunology department of School of Public Health and Institute of Health Research of Tehran University of Medical Sciences. Control group will receive 1500 mg/day (three 500 mg tablets/day) of plcebo orally 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 2016-09-14 Ethics committee of Tehran University of Medical Sciences 6th floor، central building of Tehran University of Medical Sciences، On the Corner of Keshavarz Blvd، and Qods Street، Keshavarz Blvd.، Tehran، Iran. Tehran Iran (Islamic Republic of)