Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

Not Applicable

• Conditions: Rheumatoid Arthritis
• Interventions: Dietary Supplement: RYR; Dietary Supplement: Tea

• Registration Number: NCT02257047
• Lead Sponsor: Chengdu PLA General Hospital

Brief Summary

To evaluate the effect of red yeast rice on subclinical atherosclerosis in patients with rheumatoid arthritis

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-03
• Study First Posted: 2014-10-06
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-30
• Last Update Posted: 2017-10-03
• Primary Completion: 2018-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RYR	RYR	Patients under the treatment of red yeast rice
Control	Tea	Patients under the treatment of tea

Primary Outcome Measures

Name	Time	Method
Changes from baseline in Carotid intima-media thickness at 24 weeks	At 0 week, 12 weeks, 24 weeks

Trial Locations

Locations (1)

General Hospital of Chengdu Military Area Command PLA; 🇨🇳 Chengdu, Sichuan, China