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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02219191
Other study ID # PTSTA20141102
Secondary ID
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
Health authority
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

Study Design


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
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