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The purpose of this study is to evaluate the effect of Qingkailing injection versus Puerarin injection on withdrawal rate of corticosteroids in patients with active rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Puerarin injection 400 mg | Active Comparator | Patients under the treatment of Puerarin injection 400 mg,daily,for 24 weeks |
|
| Qingkailing injection 40 ml | Experimental | Patients under the treatment of Qingkailing injection 40 ml,daily,for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Puerarin injection 400 mg | Drug |
| ||
| Qingkailing injection 40 ml |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in corticosteroids withdrawal rate at 24 weeks | The number (rate) of patients who do not need the use of corticosteroids any more were monitored 0 week, 12 weeks, 24 weeks. | At 0 week, 12 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Disease activity score in 28 joints(DAS28) | Disease activity of RA is assessed using disease activity score in 28 joints (DAS28). DAS28 = 0.56 • √(tender joint count) + 0.28 •√(swollen joint count) + 0.70 In(ESR) + 0.014(global health on visual analogue scale).DAS28 will be assessed at At 0 week, 12 weeks and 24 weeks | At 0 week, 12 weeks, 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Chengdu Military Area Command PLA | Chengdu | 610083 | China |
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| Drug |
|
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C033607 | puerarin |
| C504928 | Qingkailing |
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