<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02257047</url>
  </required_header>
  <id_info>
    <org_study_id>RYR20140104</org_study_id>
    <nct_id>NCT02257047</nct_id>
  </id_info>
  <brief_title>Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chengdu PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chengdu PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effect of red yeast rice on subclinical atherosclerosis in patients with&#xD;
      rheumatoid arthritis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">March 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline in Carotid intima-media thickness at 24 weeks</measure>
    <time_frame>At 0 week, 12 weeks, 24 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>RYR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients under the treatment of red yeast rice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients under the treatment of tea</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Tea</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>RYR</intervention_name>
    <description>red yeast rice</description>
    <arm_group_label>RYR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with a definite diagnose of rheumatoid arthritis(RA) were included if they&#xD;
             met the classification criteria for RA established by the American Rheumatism&#xD;
             Association (ACR) and European League Against Rheumatism (EULAR) in 2010&#xD;
&#xD;
          -  aged from 18 to 75 years&#xD;
&#xD;
          -  without conflict to the written, informed consent signed prior to the enrollment&#xD;
&#xD;
          -  no severe hepatic or renal disorders&#xD;
&#xD;
          -  no known carotid artery stenosis&#xD;
&#xD;
          -  no coagulation disorders&#xD;
&#xD;
          -  no hypertension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  being in pregnancy, lactation period or under a pregnancy plan&#xD;
&#xD;
          -  being allergic to the test drug&#xD;
&#xD;
          -  not compatible for the trial medication&#xD;
&#xD;
          -  without full legal capacity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>General Hospital of Chengdu Military Area Command PLA</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610083</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>September 30, 2017</last_update_submitted>
  <last_update_submitted_qc>September 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chengdu PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Yang Min</investigator_full_name>
    <investigator_title>Ph.D</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02257047
org study id: RYR20140104
nct id: NCT02257047
lead sponsor: 
has dmc: Yes
To evaluate the effect of red yeast rice on subclinical atherosclerosis in patients with
      rheumatoid arthritis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Changes from baseline in Carotid intima-media thickness at 24 weeks
time frame: At 0 week, 12 weeks, 24 weeks
arm group label: RYR
arm group type: Experimental
description: Patients under the treatment of red yeast rice
arm group label: Control
arm group type: Sham Comparator
description: Patients under the treatment of tea
intervention type: Dietary Supplement
intervention name: Tea
arm group label: Control
intervention type: Dietary Supplement
intervention name: RYR
description: red yeast rice
arm group label: RYR
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chengdu PLA General Hospital
investigator full name: Yang Min
investigator title: Ph.D
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid