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NCT02257047 Clinical Trial

Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02257047
Other study ID # RYR20140104
Secondary ID
Status Enrolling by invitation
Phase N/A
First received October 2, 2014
Last updated September 30, 2017
Start date October 2014
Est. completion date March 2019

Study information
Verified date September 2017
Source Chengdu PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 120
Est. completion date March 2019
Est. primary completion date March 2018
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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Tea

• RYR
red yeast rice

Locations
Country Name City State
China General Hospital of Chengdu Military Area Command PLA Chengdu Sichuan

Sponsors (1)
Lead Sponsor Collaborator
Chengdu PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes from baseline in Carotid intima-media thickness at 24 weeks At 0 week, 12 weeks, 24 weeks
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