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

Chengdu PLA General Hospital

Status: Unknown

Conditions: Rheumatoid Arthritis

Treatments: Drug: Atorvastatin tablet 20 mg; Drug: puerarin tablet 50 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02219191

PTSTA20141102

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 2 patient groups

puerarin tablet 50 mg

Experimental group

Description:

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.

Treatment:

Drug: puerarin tablet 50 mg

Atorvastatin tablet 20 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Atorvastatin tablet 20 mg