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Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

NCT ID: NCT02257047

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-03-31

Brief Summary

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

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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RYR

Patients under the treatment of red yeast rice

Group Type EXPERIMENTAL

RYR

Intervention Type DIETARY_SUPPLEMENT

red yeast rice

Control

Patients under the treatment of tea

Group Type SHAM_COMPARATOR

Tea

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Tea

Intervention Type DIETARY_SUPPLEMENT

RYR

red yeast rice

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chengdu PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yang Min

Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General Hospital of Chengdu Military Area Command PLA

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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RYR20140104

Identifier Type: -

Identifier Source: org_study_id