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

January 15, 2018 updated by: Yang Min, Chengdu PLA General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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

Interventional

Enrollment (Actual)

119

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Routine anti-rheumatic drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 0 week, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
low-density lipoprotein cholesterol (LDL-C)
Time Frame: at 0 week, 12 weeks, 24 weeks
at 0 week, 12 weeks, 24 weeks
erythrocyte sedimentation rate (ESR)
Time Frame: at 0 week, 12 weeks, 24 weeks
at 0 week, 12 weeks, 24 weeks
C reactive protein (CRP)
Time Frame: at 0 week, 12 weeks, 24 weeks
at 0 week, 12 weeks, 24 weeks
Total cholesterol (TC)
Time Frame: at 0 week, 12 weeks, 24 weeks
at 0 week, 12 weeks, 24 weeks
triglycerides (TGs)
Time Frame: at 0 week, 12 weeks, 24 weeks
at 0 week, 12 weeks, 24 weeks
tumor necrosis factor (TNFα)
Time Frame: at 0 week，12 weeks, 24 weeks
at 0 week，12 weeks, 24 weeks
interleukin-8 (IL-8)
Time Frame: at 0 week，12 weeks, 24 weeks
at 0 week，12 weeks, 24 weeks
interleukin-1 (IL-1)
Time Frame: at 0 week，12 weeks, 24 weeks
at 0 week，12 weeks, 24 weeks
interleukin-6 (IL-6)
Time Frame: at 0 week，12 weeks, 24 weeks
at 0 week，12 weeks, 24 weeks
disease activity score in 28 joints (DAS28)
Time Frame: at 0 week，12 weeks, 24 weeks
at 0 week，12 weeks, 24 weeks
homeostasis model assessment (HOMA-IR)
Time Frame: at 0 week，12 weeks, 24 weeks
at 0 week，12 weeks, 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 0 week, 12 weeks, 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
at 0 week, 12 weeks, 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
at 0 week, 12 weeks, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu PLA General Hospital

Investigators

  • Principal Investigator: Min Yang, Ph.D., General Hospital of Chengdu Military Area Command PLA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

October 1, 2014

First Posted (Estimate)

October 2, 2014

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 15, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-2012-063
  • No. BWS11J067 (Other Grant/Funding Number: Scientific Research Funds Project of Chinese PLA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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