NCT02254655

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Chengdu PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2013-11-01
• Primary completion: 2017-09-01
• Completion: 2017-11-01
• First posted: 2014-10-02
• Last updated: 2018-01-17