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IRCT2016111313739N6 IRCT 2017-01-12 Vice chancellor for Research, Tehran University of Medical Sciences The therapeutic effects of β, D, Mannuronic acid in patients with multiple sclerosis A randomized controlled trial of β, D, Mannuronic acid compared with interferon,beta on clinical signs and symptoms and magnetic resonance imaging (MRI) in multiple sclerosis patients 2017-04-21 anticipated 36 Complete https://irct.ir/trial/13521 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Other design features: The method of blinding in this study is so neither patients participated in the study nor the persons who perform the test will aware of the intervention. 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. 2 multiple sclerosis. Intervention 1: The intervention group will receive 1500 mg/day (three 500 mg tablets/day) of Beta, D, Mannuronic acid orally for 24 weeks. The Beta, D, Mannuronic 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 placebo orally for 24 weeks.
public Dr. Abbas Mirshafiey
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences, 16th Azar St., Enghelab Sq., Tehran
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, 16th Azar St., Enghelab Sq., Tehran
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: 18-60 years old patients, diagnosed with multiple sclerosis who were injecting different forms interferon,beta (interferon beta, 1a, interferon beta, 1b) at least 6 months before the trial. Also, the patients have been chosen by neurologist among active patients on the basis of disease activity who have had at least one relapsing period during one year or have active lesions in their MRI imaging. Written informed consent will be obtained; Exclusion Criteria: History of fever and Infectious diseases, Positive pregnancy test or Lactation, Other collagen vascular diseases, Other autoimmune diseases, Malignancies, Patients have enrolled another clinical trial study within last 4 weeks, Other concomitant diseases (Hepatic, renal, hematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease). 18 years 60 years Both G35 Multiple sclerosis Treatment - Drugs Placebo The intervention group will receive 1500 mg/day (three 500 mg tablets/day) of Beta, D, Mannuronic acid orally for 24 weeks. The Beta, D, Mannuronic 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 placebo orally for 24 weeks. Active lesion in MRI imaging. Timepoint: At baseline and after 24 weeks of treatment. Method of measurement: imaging by MRI method. The number of relapsing periods. Timepoint: At baseline and after 24 weeks of treatment. Method of measurement: medical history and questionnaire. Serum level of IL-6. Timepoint: At baseline and after 24 weeks of treatment. Method of measurement: ELISA test. Serum level of TNF-α. Timepoint: At baseline and after 24 weeks of treatment. Method of measurement: ELISA test. IL-1β expression. Timepoint: At baseline and after 24 weeks of treatment. Method of measurement: Real-time PCR. IL-17 expression. Timepoint: At baseline and after 24 weeks of treatment. Method of measurement: Real-time PCR. Iranian Center of Neurological Research Vice chancellor for Research, Tehran University of Medical Sciences Iranian Center of Neurological Research Approved 2016-09-18 Ethics committee of Tehran University of Medical Sciences 6th floor, Headquarter for Tehran University of Medical Sciences, On the Corner of Keshavarz Blvd. and Qods Street, Keshavarz Blvd Tehran Iran (Islamic Republic of)