A Clinical Study of Xin'an Medicine in the Treatment of Bi Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Xinfeng Capsule in the Treatment of Rheumatoid Arthritis (RA):A Randomized, Double-blind, Double-dummy, Multi-center Trial

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Xinfeng capsule
* Drug: leflunomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of RA, classified by American Rheumatism Association 1987 revised criteria. According with the Zheng diagnosis of Traditional Chinese Medicine. age from 18 to 65 years. For patients currently receiving non-steroidal anti-inflammatory drugs (NSAIDs): Treatment at a stable dose during last 4 weeks prior to screening，or Patients do not take NSAIDs at least 1 weeks prior to screening. Patients not taking DMARDs at least 4 weeks prior to screening. Patients taking corticosteroids (≤15mg prednisone or Equivalent) ≥4 weeks before entering the trial. Patients agree to participate in this study and sign the informed consent form. Exclusion Criteria: Patients have received intra-articular or systemic corticosteroid injection within 4 weeks of screening. Patients have high disease activity (DAS28-3 scores> 5.1). Patients have diagnosed any other chronic inflammatory disease or connective tissue disease like sicca syndrome（SS）, systemic lupus erythematosus (SLE)etc; Patients with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system ; Patients who are pregnant or nursing mothers or Psychiatric patients. Patients with active gastroduodenal ulcer or gastritis which caused by long-term use of NSAIDs; The patient who has known hypersensitivity to trial medicine . Patients have participated in other clinical trials within 4 weeks of screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xinfeng capsule & placebo<br>Xinfeng capsule:Three each time, 3 times a day, Oral,for 3 months placebo(for leflunomide): 10 mg each time, 1 time a day, Oral,for3 months | Drug: Xinfeng capsule<br>* 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<br>|
| Active Comparator: leflunomide & placebo<br>leflunomide :10mg each time, one time a day, by mouth,for 3 months placebo(for xinfeng capsule):Three each time, 3 times a day, Oral,for3 months | Drug: leflunomide<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 (American College of Rheumatology (ACR) criteria of 20% improvement in symptoms ) | ACR20 used for evaluating the efficacy of rheumatoid arthritis (RA). | baseline,week4,week8,week12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR50 (American College of Rheumatology (ACR) criteria of 50% improvement in symptoms ) | ACR50 used for evaluating the efficacy of rheumatoid arthritis (RA). | 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). | baseline,week4,week8，week12 | 
| Patterns based on Chinese medicine(CM)symptoms |  | baseline,week4,week8，week12 | 
| Disease Activity Scale (DAS)28 |  | 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 | 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. | baseline,week12 | 
| x-rays of the hands and wrists |  | baseline,week12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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xinfeng capsule;, rheumatoid arthritis (RA);, randomized;, double-blind;