Puerarin Versus Atorvastatin in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases

Study Overview
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Brief Summary
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To evaluate the Effect of Puerarin tablets versus statins in treating metabolism syndrome in patients with chronic rheumatic diseases

Official Title
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The Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: puerarin tablet 50 mg
* Drug: Atorvastatin tablet 20 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with a definite diagnose with rheumatic disease patients with metabolic Syndrome without conflict to the written, informed consent signed prior to the enrollment no severe hepatic or renal disorders no known carotid artery stenosis no coagulation disorders no hypertension Exclusion Criteria: being in pregnancy, lactation period or under a pregnancy plan being allergic to the test drug not compatible for the trial medication without full legal capacity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: puerarin tablet 50 mg<br>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. | Drug: puerarin tablet 50 mg<br> <br> * Other names: C15H10O4254.24;|
| Active Comparator: Atorvastatin tablet 20 mg<br>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. | Drug: Atorvastatin tablet 20 mg<br>* Approval No.: H19990258<br>* Other names: (3r,5rr)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-yl-pyrrol-1-yl]-3,5-dihydroxy-heptanoic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in homeostasis model assessment (HOMA-IR) |  | At 0 week, 12 weeks, 24 weeks and 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Puerarin tablet, rheumatoid arthritis, metabolism syndrome