<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/NCT02264301</url>
  </required_header>
  <id_info>
    <org_study_id>QKL20140588</org_study_id>
    <nct_id>NCT02264301</nct_id>
  </id_info>
  <brief_title>Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid Arthritis</brief_title>
  <official_title>The Effect of Qingkailing Injection on Corticosteroids Withdrawal Rate in Patients With Active Rheumatoid Arthritis</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>
      The purpose of this study is to evaluate the effect of Qingkailing injection versus Puerarin&#xD;
      injection on withdrawal rate of corticosteroids in patients with active rheumatoid arthritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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 corticosteroids withdrawal rate at 24 weeks</measure>
    <time_frame>At 0 week, 12 weeks, 24 weeks</time_frame>
    <description>The number (rate) of patients who do not need the use of corticosteroids any more were monitored 0 week, 12 weeks, 24 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Disease activity score in 28 joints(DAS28)</measure>
    <time_frame>At 0 week, 12 weeks, 24 weeks</time_frame>
    <description>Disease activity of RA is assessed using disease activity score in 28 joints (DAS28). DAS28 = 0.56 • √(tender joint count) + 0.28 •√(swollen joint count) + 0.70 In(ESR) + 0.014(global health on visual analogue scale).DAS28 will be assessed at At 0 week, 12 weeks and 24 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Puerarin injection 400 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients under the treatment of Puerarin injection 400 mg,daily,for 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Qingkailing injection 40 ml</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients under the treatment of Qingkailing injection 40 ml,daily,for 24 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Puerarin injection 400 mg</intervention_name>
    <arm_group_label>Puerarin injection 400 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Qingkailing injection 40 ml</intervention_name>
    <arm_group_label>Qingkailing injection 40 ml</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  with active RA&#xD;
&#xD;
          -  without taking any other medication for the treatment of active RA in at least 4 last&#xD;
             weeks&#xD;
&#xD;
          -  aged from 18 to 75 years&#xD;
&#xD;
          -  without conflict to the written, informed consent signed prior to the enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  being included in other clinical trial within the last 4 weeks&#xD;
&#xD;
          -  with abnormal liver or kidney function (more than 1 time above the high normal)&#xD;
&#xD;
          -  with serious cardiovascular disease&#xD;
&#xD;
          -  with hematologic disease&#xD;
&#xD;
          -  being in pregnancy, lactation period or under a pregnancy plan&#xD;
&#xD;
          -  with severe gastrointestinal disease&#xD;
&#xD;
          -  with contraindication or being allergic to the test drugs&#xD;
&#xD;
          -  being under the treatment of drugs within 1 previous week, that might affect the&#xD;
             results of the trial, such as non-steroidal anti-inflammatory drugs, steroidal&#xD;
             anti-inflammatory drugs, immunosuppressants, anti-ulcer drugs&#xD;
&#xD;
          -  being not compatible for the trial medication, or other circumstances at the&#xD;
             discretion of investigators&#xD;
&#xD;
          -  without legal capacity or only with limited 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>
        <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>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 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>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Puerarin</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/NCT02264301
org study id: QKL20140588
nct id: NCT02264301
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the effect of Qingkailing injection versus Puerarin
      injection on withdrawal rate of corticosteroids in patients with active rheumatoid arthritis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline in corticosteroids withdrawal rate at 24 weeks
time frame: At 0 week, 12 weeks, 24 weeks
description: The number (rate) of patients who do not need the use of corticosteroids any more were monitored 0 week, 12 weeks, 24 weeks.
measure: Change from baseline in Disease activity score in 28 joints(DAS28)
time frame: At 0 week, 12 weeks, 24 weeks
description: Disease activity of RA is assessed using disease activity score in 28 joints (DAS28). DAS28 = 0.56 • √(tender joint count) + 0.28 •√(swollen joint count) + 0.70 In(ESR) + 0.014(global health on visual analogue scale).DAS28 will be assessed at At 0 week, 12 weeks and 24 weeks
arm group label: Puerarin injection 400 mg
arm group type: Active Comparator
description: Patients under the treatment of Puerarin injection 400 mg,daily,for 24 weeks
arm group label: Qingkailing injection 40 ml
arm group type: Experimental
description: Patients under the treatment of Qingkailing injection 40 ml,daily,for 24 weeks
intervention type: Drug
intervention name: Puerarin injection 400 mg
arm group label: Puerarin injection 400 mg
intervention type: Drug
intervention name: Qingkailing injection 40 ml
arm group label: Qingkailing injection 40 ml
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: Puerarin