Evaluation of the therapeutic efficacy of Mannuronic Acid in Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis.Seropositive Rheumatoid Arthritis
- Registration Number
- IRCT2017100213739N10
- Lead Sponsor
- Vice-Chancellor for Research, Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 203
Inclusion Criteria:
1.Patients should be 18-65 year old, afflicted by Rheumatoid Arthritis, diagnosed based on the American College of Rheumatology (ACR) Diagnostic Criteria by a rheumatology specialist after evaluating the clinical parameters such as ESR, RF, CRP and Anti-CCP.
2.Each patient must sign written informed consent.
3.The disease in all patients should be in active form (DAS28>2.6)
4.None of patients must suffer from another concomitant diseases like Hepatic, renal, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral diseases.
1.History of fever and Infectious diseases, positive pregnancy test or lactation, other collagen- vascular diseases, other auto-immune diseases and Malignancies.
2.Enrolling in another clinical trial study within last 4 weeks
3.Suffering from other concomitant diseases such as hepatic, renal, hematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.