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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

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Puerarin injection 400 mg Drug: Control Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis, a Controlled and Randomized Trial
Actual Study Start Date : November 2013
Actual Primary Completion Date : September 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254655


Sponsors and Collaborators
Chengdu PLA General Hospital
Investigators
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Principal Investigator: Min Yang, Ph.D. General Hospital of Chengdu Military Area Command PLA
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yang Min, Dr., Chengdu PLA General Hospital
ClinicalTrials.gov Identifier: NCT02254655    
Other Study ID Numbers: E-2012-063
No. BWS11J067 ( Other Grant/Funding Number: Scientific Research Funds Project of Chinese PLA )
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Keywords provided by Yang Min, Chengdu PLA General Hospital:
puerarin
rheumatoid arthritis
atherosclerosis
carotid intima-media thickness
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Puerarin
Vasodilator Agents