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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02219191
Date of registration:	16/07/2014
Prospective Registration:	Yes
Primary sponsor:	Chengdu PLA General Hospital
Public title:	Puerarin Versus Atorvastatin in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases
Scientific title:	The Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases
Date of first enrolment:	August 2014
Target sample size:	150
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/show/NCT02219191
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
Phase:	N/A

Countries of recruitment
China

Contacts

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: puerarin tablet 50 mg

Drug: Atorvastatin tablet 20 mg

Primary Outcome(s)

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

Secondary Outcome(s)

blood cell count [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]

Fasting serum total cholesterol (TC) [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]

Fasting serum triglycerides (TGs) [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]

C reactive protein (CRP) [Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks]

Liver function [Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks]

Kidney function [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]

tumor necrosis factor (TNFa) [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]

Fasting serum insulin [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]

Fasting serum low-density lipoprotein cholesterol (LDL-C) [Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks]

Secondary ID(s)

PTSTA20141102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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