Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments puerarin tablet 50 mg, atorvastatin tablet 20 mg
Sponsor Chengdu PLA General Hospital
Start date August 2014
End date December 2018
Trial size 150 participants
Trial identifier NCT02219191, PTSTA20141102

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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.
puerarin tablet 50 mg C15H10O4254.24
(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.
atorvastatin tablet 20 mg (3r,5rr)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-yl-pyrrol-1-yl]-3,5-dihydroxy-heptanoic acid
Approval No.: H19990258

Primary Outcomes

Measure
Change from baseline in homeostasis model assessment (HOMA-IR)
time frame: At 0 week, 12 weeks, 24 weeks and 48 weeks

Secondary Outcomes

Measure
Fasting serum low-density lipoprotein cholesterol (LDL-C)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum high-density lipoprotein cholesterol (HDL-C)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
erythrocyte sedimentation rate (ESR)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
C reactive protein (CRP)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum total cholesterol (TC)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum triglycerides (TGs)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
tumor necrosis factor (TNFα)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
interleukin-8 (IL-8)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
interleukin-1 (IL-1)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
interleukin-6 (IL-6)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum insulin
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum glucose
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Kidney function
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Liver function
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
blood cell count
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title The Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Chengdu PLA General Hospital.