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Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tea
RYR
Sponsored by
Chengdu PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital of Chengdu Military Area Command PLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

RYR

Control

Arm Description

Patients under the treatment of red yeast rice

Patients under the treatment of tea

Outcomes

Primary Outcome Measures

Changes from baseline in Carotid intima-media thickness at 24 weeks

Secondary Outcome Measures

Full Information

First Posted
October 2, 2014
Last Updated
September 30, 2017
Sponsor
Chengdu PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02257047
Brief Title
Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chengdu PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RYR
Arm Type
Experimental
Arm Description
Patients under the treatment of red yeast rice
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Patients under the treatment of tea
Intervention Type
Dietary Supplement
Intervention Name(s)
Tea
Intervention Type
Dietary Supplement
Intervention Name(s)
RYR
Intervention Description
red yeast rice
Primary Outcome Measure Information:
Title
Changes from baseline in Carotid intima-media thickness at 24 weeks
Time Frame
At 0 week, 12 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
General Hospital of Chengdu Military Area Command PLA
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610083
Country
China

12. IPD Sharing Statement

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Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

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