CClinicalTrials.gg
Status unknownNCT02219191Updated Apr 4, 2017

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

An interventional study of puerarin tablet 50 mg and Atorvastatin tablet 20 mg in Rheumatoid Arthritis, sponsored by Chengdu PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-04.

Sponsored by Chengdu PLA General Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Puerarin tablet
  • rheumatoid arthritis
  • metabolism syndrome
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 150 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Chengdu PLA General Hospital is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Drugpuerarin tablet 50 mg

    Also known as: C15H10O4254.24

  • DrugAtorvastatin tablet 20 mg

    Approval No.: H19990258

    Also known as: (3r,5rr)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-yl-pyrrol-1-yl]-3,5-dihydroxy-heptanoic acid

06

What researchers measure

Primary outcomes

  1. Change from baseline in homeostasis model assessment (HOMA-IR)

    Time frame: At 0 week, 12 weeks, 24 weeks and 48 weeks

Secondary outcomes

  1. Fasting serum low-density lipoprotein cholesterol (LDL-C)

    Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

  2. Fasting serum high-density lipoprotein cholesterol (HDL-C)

    Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

  3. erythrocyte sedimentation rate (ESR)

    Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

  4. C reactive protein (CRP)

    Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

  5. Fasting serum total cholesterol (TC)

    Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

  6. Fasting serum triglycerides (TGs)

    Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

  7. tumor necrosis factor (TNFα)

    Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

  8. interleukin-8 (IL-8)

    Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

  9. interleukin-1 (IL-1)

    Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

  10. interleukin-6 (IL-6)

    Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

  11. Fasting serum insulin

    Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

  12. Fasting serum glucose

    Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

  13. Kidney function

    Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

  14. Liver function

    Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

  15. blood cell count

    Time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks

07

Study locations

1 site
  • 270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA,
    Chengdu city, Sichuan 610083, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02219191
Lead sponsor
Chengdu PLA General Hospital
Responsible party
Yang Min (Ph.D, Chengdu PLA General Hospital) — Principal investigator
First posted
Aug 18, 2014
Start date
Aug 2014
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Apr 4, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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