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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Puerarin injection 400 mg
* Drug: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Puerarin injection 400 mg<br>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<br>* 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.<br>* Other names: Puerarin injection 400 mg + routine anti-rheumatic drugs;|
| Sham Comparator: Control<br>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<br>* 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<br>* Other names: Routine anti-rheumatic drugs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Carotid intima-media thickness at 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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-1 (IL-1) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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puerarin, rheumatoid arthritis, atherosclerosis, carotid intima-media thickness