multiple sclerosis. Multiple sclerosis
Conditions
Interventions
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
Treatment - Drugs
Placebo
Control group will receive 1500 mg/day (three 500 mg tablets/day) of placebo orally for 24 weeks.
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 pow
Sponsors
Vice chancellor for Research, Tehran University of Medical Sciences
Iranian Center of Neurological Research
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum level of IL-6. Timepoint: At baseline and after 24 weeks of treatment. Method of measurement: ELISA test.;Serum level of TNF-a. Timepoint: At baseline and after 24 weeks of treatment. Method of measurement: ELISA test.;IL-1ß 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Abbas Mirshafiey
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences
Outcome results
None listed