Therapeutic effect of Guluronat on disease severity in MS

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2017
INTERVENTION: 25 pationts as control group use only their conventional drug(Interferon beta). Intervention 1: The intervention group will receive 1000mg/day (two 500 mg tablets/day) of a‐L‐Guluronic acid orally for 24 weeks. The a‐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: 25 pationts as control group use only their conventional drug(Interferon beta). The intervention group will receive 1000mg/day (two 500 mg tablets/day) of a‐L‐Guluronic acid orally for 24 weeks. The a‐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. Treatment ‐ Drugs CONDITION: Multiple Sclerosis Multiple Sclerosis. ; Multiple Sclerosis PRIMARY OUTCOME: Active lesion in MRI imaging. Timepoint: At baseline and after 24 weeks of treatment. Method of measurement: imaging by MRI method. SECONDARY OUTCOME: Serum level of ALT. Timepoint: At baseline and after 24 weeks of treatment. Method of measurement: Biochemical measurements. Serum level of uric acid. Timepoint: At baseline and after 24 weeks of treatment. Method of measurement: Biochemical measurements. Serum level of AST. Timepoint: At baseline and after 24 weeks of treatment. Method of measurement: Biochemical measurements. Serum level of BUN. Timepoint: At baseline and after 24 weeks of treatment. Method of measurement: Biochemical measurements. INCLUSION CRITERIA: INCLUSION CRITERIA: 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 6month 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).
Epistemonikos ID: 94e03ac58a52d599b844ea571a86ce94ae106e20
First added on: Mar 31, 2022