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

Chengdu PLA General Hospital

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Puerarin injection 400 mg; Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02254655

No. BWS11J067 (Other Grant/Funding Number)

E-2012-063

Details and patient eligibility

About

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.

Full 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

Enrollment: 119 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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119 participants in 2 patient groups

Puerarin injection 400 mg

Experimental group

Description:

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.

Treatment:

Drug: Puerarin injection 400 mg

Control

Sham Comparator group

Description:

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.

Treatment:

Drug: Control