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To evaluate the Effect of Puerarin tablets versus statins in treating metabolism syndrome in patients with chronic rheumatic diseases
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| puerarin tablet 50 mg | Experimental | Patients were orally administrated with 50 mg puerarin tablet three times a day for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, bone metabolism regulators and gastric mucosal protective agents on as-needed basis. |
|
| Atorvastatin tablet 20 mg | Active Comparator | Patients were orally administrated with 20 mg Atorvastatin tablet once a day for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, bone metabolism regulators and gastric mucosal protective agents on as-needed basis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| puerarin tablet 50 mg | Drug |
|
| |
| Atorvastatin tablet 20 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in homeostasis model assessment (HOMA-IR) | At 0 week, 12 weeks, 24 weeks and 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting serum low-density lipoprotein cholesterol (LDL-C) | at 0 week, 12 weeks, 24 weeks, 48 weeks | |
| Fasting serum high-density lipoprotein cholesterol (HDL-C) | at 0 week, 12 weeks, 24 weeks, 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA， | Chengdu | Sichuan | 610083 | China |
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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 |
|---|---|
| C033607 | puerarin |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Approval No.: H19990258 |
|
|
| erythrocyte sedimentation rate (ESR) | at 0 week, 12 weeks, 24 weeks, 48 weeks |
| C reactive protein (CRP) | at 0 week, 12 weeks, 24 weeks, 48 weeks |
| Fasting serum total cholesterol (TC) | at 0 week, 12 weeks, 24 weeks, 48 weeks |
| Fasting serum triglycerides (TGs) | at 0 week, 12 weeks, 24 weeks, 48 weeks |
| tumor necrosis factor (TNFα) | at 0 week, 12 weeks, 24 weeks, 48 weeks |
| interleukin-8 (IL-8) | at 0 week, 12 weeks, 24 weeks, 48 weeks |
| interleukin-1 (IL-1) | at 0 week, 12 weeks, 24 weeks, 48 weeks |
| interleukin-6 (IL-6) | at 0 week, 12 weeks, 24 weeks, 48 weeks |
| Fasting serum insulin | at 0 week, 12 weeks, 24 weeks, 48 weeks |
| Fasting serum glucose | at 0 week, 12 weeks, 24 weeks, 48 weeks |
| Kidney function | at 0 week, 12 weeks, 24 weeks, 48 weeks |
| Liver function | at 0 week, 12 weeks, 24 weeks, 48 weeks |
| blood cell count | at 0 week, 12 weeks, 24 weeks, 48 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |