Bi Syndrome is one of Traditional Chinese Medicine(TCM)name, It means an obstruction in Chinese,and it refers the syndrome characterized by the obstruction of qi and blood in the meridians due to the invasion of external pathogenic wind,cold and dampness, manifested as soreness, pain, numb,etc. Bi Syndrome contains Rheumatoid arthritis(RA). RA is a chronic disease affecting more than 20 million people in the world.It is one of the most common forms of autoimmune disease. Xin'an Medicine is one of Traditional Chinese Medicine which originated from AnHui. Xinfeng Capsule developed according to the Xin'an medicine theory ,and it has long been adopted for treatment of rheumatoid arthritis (RA). The study is aimed to evaluate the effectiveness and safety of Xinfeng Capsule in the treatment of RA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
304
Xinfeng capsule:Three each time, 3 times a day, Oral,for 3 months; placebo(for leflunomide):10mg each time, 1 time a day, Oral,for 3 months; Participants will continue on the stable dose of glucocorticoids and NSAIDs that they were receiving prior to study entry
leflunomide :10mg each time, one time a day, Oral,for 3 months; placebo(for xinfeng capsule):Three each time, 3 times a day, Oral,for 3 months; Participants will continue on the stable dose of glucocorticoids and NSAIDs that they were receiving prior to study entry
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
The first affiliated hospital of anhui medical university
Hefei, Anhui, China
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, China
ACR20 (American College of Rheumatology (ACR) criteria of 20% improvement in symptoms )
ACR20 used for evaluating the efficacy of rheumatoid arthritis (RA).
Time frame: baseline,week4,week8,week12
ACR50 (American College of Rheumatology (ACR) criteria of 50% improvement in symptoms )
ACR50 used for evaluating the efficacy of rheumatoid arthritis (RA).
Time frame: baseline,week4,week8,week12
ACR70 (American College of Rheumatology (ACR) criteria of 70% improvement in symptoms )
ACR50 used for evaluating the efficacy of rheumatoid arthritis (RA).
Time frame: baseline,week4,week8,week12
Patterns based on Chinese medicine(CM)symptoms
Time frame: baseline,week4,week8,week12
Disease Activity Scale (DAS)28
Time frame: baseline,week4,week8, week12
Rheumatoid arthritis (RA) biomarkers
Rheumatoid arthritis (RA) biomarkers,including rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) ,anti-cyclic citrullinated peptide (anti-CCP) antibodies, IgG、IgA、IgM, d-dimer, the coagulation function tests
Time frame: baseline, week12
Life Quality Assessment
Life Quality Assessment,including Health Assessment Questionnaire (HAQ), Self-rating depression scale(SDS), Self-rating anxiety scale(SAS),quality of life Questionnaire with rheumatoid arthritis.
Time frame: baseline,week12
x-rays of the hands and wrists
Time frame: baseline,week12
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