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Trial record 20 of 228 for:    yeast

Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02257047
Recruitment Status : Unknown
Verified September 2017 by Yang Min, Chengdu PLA General Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : October 6, 2014
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Yang Min, Chengdu PLA General Hospital

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Dietary Supplement: Tea Dietary Supplement: RYR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : October 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RYR
Patients under the treatment of red yeast rice
Dietary Supplement: RYR
red yeast rice

Sham Comparator: Control
Patients under the treatment of tea
Dietary Supplement: Tea



Primary Outcome Measures :
  1. Changes from baseline in Carotid intima-media thickness at 24 weeks [ Time Frame: At 0 week, 12 weeks, 24 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02257047


Locations
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China, Sichuan
General Hospital of Chengdu Military Area Command PLA
Chengdu, Sichuan, China, 610083
Sponsors and Collaborators
Chengdu PLA General Hospital

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Responsible Party: Yang Min, Ph.D, Chengdu PLA General Hospital
ClinicalTrials.gov Identifier: NCT02257047     History of Changes
Other Study ID Numbers: RYR20140104
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Red yeast rice
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents