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The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02254655
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Yang Min, Chengdu PLA General Hospital

Tracking Information
First Submitted Date  ICMJE November 18, 2013
First Posted Date  ICMJE October 2, 2014
Last Update Posted Date January 17, 2018
Actual Study Start Date  ICMJE November 2013
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2014)
Changes from baseline in Carotid intima-media thickness at 24 weeks [ Time Frame: At 0 week, 12 weeks, 24 weeks ]
Carotid intima-media thickness (CIMT) was using a high-resolution B-mode ultrasound machine (iU22 xMATRIX, Philips, Germany). CIMT was measured twice by a single experienced operator using an 10-MHz linear vascular probe. Patients were let resting in a relaxed supine position, with the head turned gently to the contralateral side when the electrocardiogram was recorded. The imaging system (QLab 6.0, Philips, Germany) was applied to measure the CIMT signals from the proximal internal carotid artery (the arterial segment 10 mm distal to the carotid bifurcation), the carotid bulb and the distal common carotid artery (the arterial segment 10 mm proximal to the carotid bulb). The mean CIMT was calculated from the value of five arterial segments. All the measurement and analysis procedures were performed by a single ultra sonographer and a single reader, who were blinded to patient profiles and group assignment.
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2014)
Changes from baseline in Carotid intima-media thickness at 24 weeks [ Time Frame: At 0 week, 12 weeks, 24 weeks ]
Carotid intima-media thickness (CIMT) was measured using a high-resolution B-mode ultrasound (US) machine (iU22 xMATRIX, Philips, Andover, Massachusetts, United States). Duplex carotid US was performed by an experienced cardiologist using an 11-MHz linear vascular probe. Offline QLab 6.0 analysis system (Philips, Andover, Massachusetts, United States) was applied to measure CIMT signals from the proximal internal carotid artery (the arterial segment 1 cm distal to the carotid bifurcation), the carotid bulb and the distal common carotid artery (the arterial segment 1 cm proximal to the carotid bulb). The investigator was blinded to all clinical information. The mean CIMT was calculated from the value of five arterial segments. All the measurement and analysis procedures were performed by a single ultra sonographer and a single investigator.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2014)
  • low-density lipoprotein cholesterol (LDL-C) [ Time Frame: at 0 week, 12 weeks, 24 weeks ]
  • erythrocyte sedimentation rate (ESR) [ Time Frame: at 0 week, 12 weeks, 24 weeks ]
  • C reactive protein (CRP) [ Time Frame: at 0 week, 12 weeks, 24 weeks ]
  • Total cholesterol (TC) [ Time Frame: at 0 week, 12 weeks, 24 weeks ]
  • triglycerides (TGs) [ Time Frame: at 0 week, 12 weeks, 24 weeks ]
  • tumor necrosis factor (TNFα) [ Time Frame: at 0 week,12 weeks, 24 weeks ]
  • interleukin-8 (IL-8) [ Time Frame: at 0 week,12 weeks, 24 weeks ]
  • interleukin-1 (IL-1) [ Time Frame: at 0 week,12 weeks, 24 weeks ]
  • interleukin-6 (IL-6) [ Time Frame: at 0 week,12 weeks, 24 weeks ]
  • disease activity score in 28 joints (DAS28) [ Time Frame: at 0 week,12 weeks, 24 weeks ]
  • homeostasis model assessment (HOMA-IR) [ Time Frame: at 0 week,12 weeks, 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 1, 2014)
  • Kidney function [ Time Frame: at 0 week, 12 weeks, 24 weeks ]
    from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks
  • Liver function [ Time Frame: at 0 week, 12 weeks, 24 weeks ]
    from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks
  • blood cell count [ Time Frame: at 0 week, 12 weeks, 24 weeks ]
    from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis
Official Title  ICMJE The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis, a Controlled and Randomized Trial
Brief Summary The purpose of this study is to access the effect (week 12/week 24) of puerarin injection on carotid intima-media thickness (CIMT) in rheumatoid arthritis (RA) patients despite routine anti-rheumatic treatment.
Detailed Description
  • Controlled, randomized trial
  • RA patients under routine anti-rheumatic care were randomized to receive the treatment with or without 400 mg puerarin injection
  • Assessments were made at entry, 12 and 24 weeks
  • The overall sample size was assessed before the enrollment
  • Randomization was performed using concealed random allocation method
  • The collected data was processed and assessed by two reviewers
  • All the measurement and analysis procedures concerning CIMT were performed by a single ultra sonographer and a single reader, who were blinded to patient profiles and group assignment
  • The reproducibility of the ultrasonographic method was test before the trial
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Puerarin injection 400 mg
    Patients receive treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.Furthermore, patients were administrated with 400 mg intravenously infused puerarin injection once a day.Each treatment course lasted for 2 weeks followed by a regular time interval of 15 days.
    Other Name: Puerarin injection 400 mg + routine anti-rheumatic drugs
  • Drug: Control
    Patients receive treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis
    Other Name: Routine anti-rheumatic drugs
Study Arms  ICMJE
  • Experimental: Puerarin injection 400 mg
    Patients were administrated with 400 mg intravenously infused puerarin injection once a day. Puerarin injection was prepared in 250 mL 0.9% sodium chloride injection before the use. The treatment course consisted of 2 weeks followed by a 15-day interval for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.
    Intervention: Drug: Puerarin injection 400 mg
  • Sham Comparator: Control
    Patients receive routine anti-rheumatic care only. Patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.
    Intervention: Drug: Control
Publications * Yang M, Luo Y, Liu T, Zhong X, Yan J, Huang Q, Tao J, He Q, Guo M, Hu Y. The Effect of Puerarin on Carotid Intima-media Thickness in Patients With Active Rheumatoid Arthritis: ARandomized Controlled Trial. Clin Ther. 2018 Oct;40(10):1752-1764.e1. doi: 10.1016/j.clinthera.2018.08.014. Epub 2018 Sep 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2014)
119
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with a definite diagnose of rheumatoid arthritis(RA) were included if they met the classification criteria for RA established by the American Rheumatism Association (ACR) and European League Against Rheumatism (EULAR) in 2010
  • aged from 18 to 75 years
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries China
 
Administrative Information
NCT Number  ICMJE NCT02254655
Other Study ID Numbers  ICMJE E-2012-063
No. BWS11J067 ( Other Grant/Funding Number: Scientific Research Funds Project of Chinese PLA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yang Min, Chengdu PLA General Hospital
Study Sponsor  ICMJE Chengdu PLA General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Min Yang, Ph.D. General Hospital of Chengdu Military Area Command PLA
PRS Account Chengdu PLA General Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP