- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02257047
Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
September 30, 2017 updated by: Yang Min, Chengdu PLA General Hospital
To evaluate the effect of red yeast rice on subclinical atherosclerosis in patients with rheumatoid arthritis
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610083
- General Hospital of Chengdu Military Area Command PLA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RYR
Patients under the treatment of red yeast rice
|
red yeast rice
|
Sham Comparator: Control
Patients under the treatment of tea
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes from baseline in Carotid intima-media thickness at 24 weeks
Time Frame: At 0 week, 12 weeks, 24 weeks
|
At 0 week, 12 weeks, 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
March 1, 2019
Study Registration Dates
First Submitted
October 2, 2014
First Submitted That Met QC Criteria
October 3, 2014
First Posted (Estimate)
October 6, 2014
Study Record Updates
Last Update Posted (Actual)
October 3, 2017
Last Update Submitted That Met QC Criteria
September 30, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RYR20140104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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