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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02254655
• Other study ID #: E-2012-063
• Secondary ID: No. BWS11J067
• Status: Completed
• Phase: Phase 2
• First received: November 18, 2013
• Last updated: January 15, 2018
• Start date: November 2013
• Est. completion date: November 2017

Study information

• Verified date: January 2018
• Source: Chengdu PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Kidney function	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
Other	Liver function	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
Other	blood cell count	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
Primary	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	low-density lipoprotein cholesterol (LDL-C)		at 0 week, 12 weeks, 24 weeks
Secondary	erythrocyte sedimentation rate (ESR)		at 0 week, 12 weeks, 24 weeks
Secondary	C reactive protein (CRP)		at 0 week, 12 weeks, 24 weeks
Secondary	Total cholesterol (TC)		at 0 week, 12 weeks, 24 weeks
Secondary	triglycerides (TGs)		at 0 week, 12 weeks, 24 weeks
Secondary	tumor necrosis factor (TNFa)		at 0 week,12 weeks, 24 weeks
Secondary	interleukin-8 (IL-8)		at 0 week,12 weeks, 24 weeks
Secondary	interleukin-1 (IL-1)		at 0 week,12 weeks, 24 weeks
Secondary	interleukin-6 (IL-6)		at 0 week,12 weeks, 24 weeks
Secondary	disease activity score in 28 joints (DAS28)		at 0 week,12 weeks, 24 weeks
Secondary	homeostasis model assessment (HOMA-IR)		at 0 week,12 weeks, 24 weeks