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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02219191
• Other study ID #: PTSTA20141102
• Status: Active, not recruiting
• Phase: N/A
• First received: July 16, 2014
• Last updated: March 31, 2017
• Start date: August 2014
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: Chengdu PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Collagen Diseases
• Rheumatic Diseases
• Rheumatoid Arthritis

Intervention

Drug:
• puerarin tablet 50 mg

• Atorvastatin tablet 20 mg
Approval No.: H19990258

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in homeostasis model assessment (HOMA-IR)		At 0 week, 12 weeks, 24 weeks and 48 weeks
Secondary	Fasting serum low-density lipoprotein cholesterol (LDL-C)		at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary	Fasting serum high-density lipoprotein cholesterol (HDL-C)		at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary	erythrocyte sedimentation rate (ESR)		at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary	C reactive protein (CRP)		at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary	Fasting serum total cholesterol (TC)		at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary	Fasting serum triglycerides (TGs)		at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary	tumor necrosis factor (TNFa)		at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary	interleukin-8 (IL-8)		at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary	interleukin-1 (IL-1)		at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary	interleukin-6 (IL-6)		at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary	Fasting serum insulin		at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary	Fasting serum glucose		at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary	Kidney function		at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary	Liver function		at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary	blood cell count		at 0 week, 12 weeks, 24 weeks, 48 weeks