Clinical trial NCT02254655: The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis
Official title: The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis, a Controlled and Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: puerarin
rheumatoid arthritis
atherosclerosis
carotid intima-media thickness
Lead sponsor: Chengdu PLA General Hospital
Sponsor class: OTHER
First posted: 2014-10-02
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in Carotid intima-media thickness at 24 weeks
timeFrame: At 0 week, 12 weeks, 24 weeks
Secondary outcomes:
measure: low-density lipoprotein cholesterol (LDL-C)
timeFrame: at 0 week, 12 weeks, 24 weeks
measure: erythrocyte sedimentation rate (ESR)
timeFrame: at 0 week, 12 weeks, 24 weeks
measure: C reactive protein (CRP)
timeFrame: at 0 week, 12 weeks, 24 weeks
measure: Total cholesterol (TC)
timeFrame: at 0 week, 12 weeks, 24 weeks
measure: triglycerides (TGs)
timeFrame: at 0 week, 12 weeks, 24 weeks
measure: tumor necrosis factor (TNFα)
timeFrame: at 0 week，12 weeks, 24 weeks
measure: interleukin-8 (IL-8)
timeFrame: at 0 week，12 weeks, 24 weeks
measure: interleukin-1 (IL-1)
timeFrame: at 0 week，12 weeks, 24 weeks
measure: interleukin-6 (IL-6)
timeFrame: at 0 week，12 weeks, 24 weeks
measure: disease activity score in 28 joints (DAS28)
timeFrame: at 0 week，12 weeks, 24 weeks
measure: homeostasis model assessment (HOMA-IR)
timeFrame: at 0 week，12 weeks, 24 weeks
Other outcomes:
measure: Kidney function
timeFrame: at 0 week, 12 weeks, 24 weeks
measure: Liver function
timeFrame: at 0 week, 12 weeks, 24 weeks
measure: blood cell count
timeFrame: at 0 week, 12 weeks, 24 weeks
Locations:
Study officials:
affiliation: General Hospital of Chengdu Military Area Command PLA
name: Min Yang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang M, Luo Y, Liu T, Zhong X, Yan J, Huang Q, Tao J, He Q, Guo M, Hu Y. The Effect of Puerarin on Carotid Intima-media Thickness in Patients With Active Rheumatoid Arthritis: ARandomized Controlled Trial. Clin Ther. 2018 Oct;40(10):1752-1764.e1. doi: 10.1016/j.clinthera.2018.08.014. Epub 2018 Sep 21.