The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: Control
- Registration Number
- NCT02254655
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control 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. Puerarin injection 400 mg 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.
- Primary Outcome Measures
Name Time Method Changes from baseline in Carotid intima-media thickness at 24 weeks 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
Name Time Method low-density lipoprotein cholesterol (LDL-C) at 0 week, 12 weeks, 24 weeks erythrocyte sedimentation rate (ESR) at 0 week, 12 weeks, 24 weeks C reactive protein (CRP) at 0 week, 12 weeks, 24 weeks Total cholesterol (TC) at 0 week, 12 weeks, 24 weeks triglycerides (TGs) at 0 week, 12 weeks, 24 weeks tumor necrosis factor (TNFα) at 0 week，12 weeks, 24 weeks interleukin-8 (IL-8) at 0 week，12 weeks, 24 weeks interleukin-6 (IL-6) at 0 week，12 weeks, 24 weeks disease activity score in 28 joints (DAS28) at 0 week，12 weeks, 24 weeks homeostasis model assessment (HOMA-IR) at 0 week，12 weeks, 24 weeks interleukin-1 (IL-1) at 0 week，12 weeks, 24 weeks