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Completed

NCT Number: NCT02254655

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arterial Occlusive Diseases Arteriosclerosis Arthritis Arthritis, Rheumatoid Atherosclerosis Autoimmune Diseases Cardiovascular Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Puerarin injection 400 mg

Drug

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 names: Puerarin injection 400 mg + routine anti-rheumatic drugs

Control

Drug

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 names: Routine anti-rheumatic drugs

Primary outcomes

  1. 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.

Secondary outcomes

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

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

  2. erythrocyte sedimentation rate (ESR)

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

  3. C reactive protein (CRP)

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

  4. Total cholesterol (TC)

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

  5. triglycerides (TGs)

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

  6. tumor necrosis factor (TNFα)

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

  7. interleukin-8 (IL-8)

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

  8. interleukin-1 (IL-1)

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

  9. interleukin-6 (IL-6)

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

  10. disease activity score in 28 joints (DAS28)

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

  11. homeostasis model assessment (HOMA-IR)

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

Other outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Chengdu PLA General Hospital

Other

Registry information

Official study title

The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis, a Controlled and Randomized Trial

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 2, 2014
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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