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

Not Applicable

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Atorvastatin tablet 20 mg; Drug: puerarin tablet 50 mg

• Registration Number: NCT02219191
• Lead Sponsor: Chengdu PLA General Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-16
• Study Start: 2014-08
• Study First Submitted QC: 2014-08-15
• Study First Posted: 2014-08-18
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-31
• Last Update Posted: 2017-04-04
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin tablet 20 mg	Atorvastatin tablet 20 mg	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.
puerarin tablet 50 mg	puerarin tablet 50 mg	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in homeostasis model assessment (HOMA-IR)	At 0 week, 12 weeks, 24 weeks and 48 weeks

Secondary Outcome Measures

Name	Time	Method
interleukin-1 (IL-1)	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
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-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

Trial Locations

Locations (1)

270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，; 🇨🇳 Chengdu city, Sichuan, China

270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，

🇨🇳Chengdu city, Sichuan, China