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| Name | Class |
|---|---|
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xinfeng capsule & placebo | Experimental |
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| leflunomide & placebo | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xinfeng capsule | Drug | 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 |
| 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 |
| 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 ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| liu jiu, doctor | The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of bengbu medical college | Bengbu | Anhui | 233004 | China | ||
| The first affiliated hospital of anhui medical university |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26591677 | Derived | Liu J, Wang Y, Huang C, Xu J, Li Z, Xu L, He L, Sun Y, Wang Y, Xu S, Zhao P, Mao T, Tan B, Zhu F, Zhang P, Fang L. Efficacy and safety of Xinfeng capsule in patients with rheumatoid arthritis: a multi-center parallel-group double-blind randomized controlled trial. J Tradit Chin Med. 2015 Oct;35(5):487-98. doi: 10.1016/s0254-6272(15)30130-8. | |
| 24299607 |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C533622 | xinfeng |
| D000077339 | Leflunomide |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| leflunomide | Drug | 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 |
|
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 |
| Hefei |
| Anhui |
| 230031 |
| China |
| Yijishan Hospital of Wannan Medical College | Wuhu | Anhui | 241001 | China |
| Liu J, Huang CB, Wang Y, Xu GQ, Cheng YY, Feng YX, Liu L, Qi YJ. Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis: study protocol of a multicenter randomized controlled trial. J Integr Med. 2013 Nov;11(6):428-34. doi: 10.3736/jintegrmed2013059. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |