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

March 31, 2017 updated by: Yang Min, Chengdu PLA General Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu city, Sichuan, China, 610083
        • 270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: puerarin tablet 50 mg
Other Names:
  • C15H10O4254.24
Active Comparator: 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.
Drug: Atorvastatin tablet 20 mg
Approval No.: H19990258
Other Names:
  • (3r,5rr)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-yl-pyrrol-1-yl]-3,5-dihydroxy-heptanoic acid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting serum low-density lipoprotein cholesterol (LDL-C)
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
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
at 0 week, 12 weeks, 24 weeks, 48 weeks
erythrocyte sedimentation rate (ESR)
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
at 0 week, 12 weeks, 24 weeks, 48 weeks
C reactive protein (CRP)
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
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
at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum triglycerides (TGs)
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
at 0 week, 12 weeks, 24 weeks, 48 weeks
tumor necrosis factor (TNFα)
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
at 0 week, 12 weeks, 24 weeks, 48 weeks
interleukin-8 (IL-8)
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
at 0 week, 12 weeks, 24 weeks, 48 weeks
interleukin-1 (IL-1)
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
at 0 week, 12 weeks, 24 weeks, 48 weeks
interleukin-6 (IL-6)
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum insulin
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
at 0 week, 12 weeks, 24 weeks, 48 weeks
Fasting serum glucose
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
at 0 week, 12 weeks, 24 weeks, 48 weeks
Kidney function
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
at 0 week, 12 weeks, 24 weeks, 48 weeks
Liver function
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
at 0 week, 12 weeks, 24 weeks, 48 weeks
blood cell count
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
at 0 week, 12 weeks, 24 weeks, 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 31, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTSTA20141102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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