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

NCT02219191 — Not applicable, Unknown, 150 participants, Chengdu PLA General Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT02219191
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	150 (Estimated)
Sponsor	Chengdu PLA General Hospital (Other)
Conditions	Rheumatoid Arthritis
Interventions	puerarin tablet 50 mg, Atorvastatin tablet 20 mg (Drug)
Dates	start 2014-08-01, primary completion 2018-12-01 (estimated), completion 2018-12-01 (estimated), first posted 2014-08-18, last updated 2017-04-04
Locations	1 site in China

-Summary

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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
puerarin tablet 50 mg	Experimental	Drug: 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.
Atorvastatin tablet 20 mg	Active comparator	Drug: 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 (Drug), also known as C15H10O4254.24
Atorvastatin tablet 20 mg (Drug), also known as (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

+Outcome measures

Primary outcomes

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

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，	Chengdu, Sichuan	China