<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/NCT02219191</url>
  </required_header>
  <id_info>
    <org_study_id>PTSTA20141102</org_study_id>
    <nct_id>NCT02219191</nct_id>
  </id_info>
  <brief_title>Puerarin Versus Atorvastatin in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases</brief_title>
  <official_title>The Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases</official_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 Puerarin tablets versus statins in treating metabolism syndrome in&#xD;
      patients with chronic rheumatic diseases&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in homeostasis model assessment (HOMA-IR)</measure>
    <time_frame>At 0 week, 12 weeks, 24 weeks and 48 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting serum low-density lipoprotein cholesterol (LDL-C)</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum high-density lipoprotein cholesterol (HDL-C)</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>erythrocyte sedimentation rate (ESR)</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C reactive protein (CRP)</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum total cholesterol (TC)</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum triglycerides (TGs)</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tumor necrosis factor (TNFα)</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin-8 (IL-8)</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin-1 (IL-1)</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin-6 (IL-6)</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum insulin</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum glucose</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kidney function</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver function</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood cell count</measure>
    <time_frame>at 0 week, 12 weeks, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>puerarin tablet 50 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were orally administrated with 50 mg puerarin tablet three times a day for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin tablet 20 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients were orally administrated with 20 mg Atorvastatin tablet once a day for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>puerarin tablet 50 mg</intervention_name>
    <arm_group_label>puerarin tablet 50 mg</arm_group_label>
    <other_name>C15H10O4254.24</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin tablet 20 mg</intervention_name>
    <description>Approval No.: H19990258</description>
    <arm_group_label>Atorvastatin tablet 20 mg</arm_group_label>
    <other_name>(3r,5rr)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-yl-pyrrol-1-yl]-3,5-dihydroxy-heptanoic acid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with a definite diagnose with rheumatic disease&#xD;
&#xD;
          -  patients with metabolic Syndrome&#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>270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，</name>
      <address>
        <city>Chengdu city</city>
        <state>Sichuan</state>
        <zip>610083</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>March 31, 2017</last_update_submitted>
  <last_update_submitted_qc>March 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 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>
  <keyword>Puerarin tablet</keyword>
  <keyword>rheumatoid arthritis</keyword>
  <keyword>metabolism syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Collagen Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Puerarin</mesh_term>
    <mesh_term>Atorvastatin</mesh_term>
  </intervention_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/NCT02219191
org study id: PTSTA20141102
nct id: NCT02219191
lead sponsor: 
has dmc: Yes
To evaluate the Effect of Puerarin tablets versus statins in treating metabolism syndrome in
      patients with chronic rheumatic diseases
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline in homeostasis model assessment (HOMA-IR)
time frame: At 0 week, 12 weeks, 24 weeks and 48 weeks
measure: Fasting serum low-density lipoprotein cholesterol (LDL-C)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: Fasting serum high-density lipoprotein cholesterol (HDL-C)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: erythrocyte sedimentation rate (ESR)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: C reactive protein (CRP)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: Fasting serum total cholesterol (TC)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: Fasting serum triglycerides (TGs)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: tumor necrosis factor (TNFα)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: interleukin-8 (IL-8)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: interleukin-1 (IL-1)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: interleukin-6 (IL-6)
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: Fasting serum insulin
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: Fasting serum glucose
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: Kidney function
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: Liver function
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: blood cell count
time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
arm group label: puerarin tablet 50 mg
arm group type: Experimental
description: Patients were orally administrated with 50 mg puerarin tablet three times a day for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.
arm group label: Atorvastatin tablet 20 mg
arm group type: Active Comparator
description: Patients were orally administrated with 20 mg Atorvastatin tablet once a day for 24 weeks. Furthermore, patients receive stable treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.
intervention type: Drug
intervention name: puerarin tablet 50 mg
arm group label: puerarin tablet 50 mg
other name: C15H10O4254.24
intervention type: Drug
intervention name: Atorvastatin tablet 20 mg
description: Approval No.: H19990258
arm group label: Atorvastatin tablet 20 mg
other name: (3r,5rr)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-yl-pyrrol-1-yl]-3,5-dihydroxy-heptanoic acid
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
mesh term: Rheumatic Diseases
mesh term: Collagen Diseases
mesh term: Puerarin
mesh term: Atorvastatin