The aim of this study is to assess the safety and effectiveness of α-L-Guluronic acid in patients with Rheumatoid Arthritis. α-L-Guluronic acid an anti-inflammatory agent that belongs to the family of nonsteroidal anti-inflammatory drugs. This drug has shown therapeutic effects with the greatest tolerability and safety in various experimental models such as experimental model of MS, rheumatoid arthritis, nephrotic syndrome and acute glomerulonephritis. In this randomized, controlled trial, thirty-six patients with Rheumatoid Arthritis fulfilling the American College of Rheumatology Diagnostic Criteria that have the active disease will be examined. Additionally, patients do not have other concomitant diseases (Hepatic, renal and cardiovascular) or malignancies. Written informed consent will be obtained. Patients will be randomly assigned to receive either α-L-Guluronic acid (treatment group, 24 patients) 1500 mg/day (three 500 mg tablets/day) or immunosuppressive drugs (control group, 12 patients) orally for 12 weeks. Medical history, clinical parameters , the serum level of CRP, ESR, RF,Anti CCP will be evaluated at baseline and 12 weeks after treatment.
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.