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Therapeutic effect of Guluronat on disease severity in MS

A randomized controlled trial of a-L-Guluronic acid compared with interferon,beta on clinical signs and symptoms and magnetic resonance imaging (MRI) in multiple sclerosis patients

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017042313739N8
Enrollment
50
Registered
2017-05-02
Start date
2017-06-06
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis. Multiple Sclerosis

Interventions

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 po
Treatment - Drugs
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, na

Sponsors

Vice chancellor for Research, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Active lesion in MRI imaging. Timepoint: At baseline and after 24 weeks of treatment. Method of measurement: imaging by MRI method.

Secondary

MeasureTime frame
Serum level of AST. 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 ALT. 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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Abbas Mirshafiey

Department of pathobiology, School of Public Health, Tehran University of Medical Sciences

mirshafiey@tums.ac.ir+98 21 8895 4913

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026