Rheumatoid Arthritis
Conditions
Keywords
Puerarin tablet, rheumatoid arthritis, metabolism syndrome
Brief summary
To evaluate the Effect of Puerarin tablets versus statins in treating metabolism syndrome in patients with chronic rheumatic diseases
Interventions
DRUGpuerarin tablet 50 mg
DRUGAtorvastatin tablet 20 mg
Approval No.: H19990258
Sponsors
Chengdu PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in homeostasis model assessment (HOMA-IR) | At 0 week, 12 weeks, 24 weeks and 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| interleukin-8 (IL-8) | 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 |
| Fasting serum low-density lipoprotein cholesterol (LDL-C) | at 0 week, 12 weeks, 24 weeks, 48 weeks |
Countries
China
Outcome results
None listed