NCT02219191

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2014

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

4.3 years

First QC Date

July 16, 2014

Last Update Submit

March 31, 2017

Conditions

Rheumatoid Arthritis

Keywords

Puerarin tabletrheumatoid arthritismetabolism syndrome

Outcome Measures

Primary Outcomes (1)

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

    At 0 week, 12 weeks, 24 weeks and 48 weeks

Secondary Outcomes (15)

  • Fasting serum low-density lipoprotein cholesterol (LDL-C)

    at 0 week, 12 weeks, 24 weeks, 48 weeks

  • Fasting serum high-density lipoprotein cholesterol (HDL-C)

    at 0 week, 12 weeks, 24 weeks, 48 weeks

  • erythrocyte sedimentation rate (ESR)

    at 0 week, 12 weeks, 24 weeks, 48 weeks

  • C reactive protein (CRP)

    at 0 week, 12 weeks, 24 weeks, 48 weeks

  • Fasting serum total cholesterol (TC)

    at 0 week, 12 weeks, 24 weeks, 48 weeks

  • +10 more secondary outcomes

Study Arms (2)

puerarin tablet 50 mg

EXPERIMENTAL

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

Atorvastatin tablet 20 mg

ACTIVE COMPARATOR

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

puerarin tablet 50 mgDRUG
Also known as: C15H10O4254.24
puerarin tablet 50 mg
Atorvastatin tablet 20 mgDRUG

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
Atorvastatin tablet 20 mg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chengdu, Sichuan, 610083, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

puerarinAtorvastatin

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

July 16, 2014

First Posted

August 18, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

CN(1)