<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/NCT02260336</url>
  </required_header>
  <id_info>
    <org_study_id>PNP01RP001</org_study_id>
    <nct_id>NCT02260336</nct_id>
  </id_info>
  <brief_title>The Effect of Panax Notoginseng Powders on Rheumatic Pain</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>
      The purpose of this study is to evaluate the effect of Panax Notoginseng Powders on Rheumatic&#xD;
      Pain.&#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">December 2018</completion_date>
  <primary_completion_date type="Anticipated">September 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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in McGill Pain Questionnaire (MPQ) score at 24 weeks</measure>
    <time_frame>at 0 week, 6 weeks, 12 weeks, 24 weeks</time_frame>
    <description>This well validated questionnaire assesses pain on several dimensions including sensory pain, affective pain, and evaluative pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Visual Analog Scale(VAS) score at 24 weeks</measure>
    <time_frame>at 0 week, 6 weeks, 12 weeks, 24 weeks</time_frame>
    <description>This rating scale involved the selection of a point along a 10-cm line, which described pain intensity on a continuum from &quot;no pain at all&quot; to &quot;pain as bad as it could be.&quot; This scale has been found to be an excellent measure of self-reported pain</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Rheumatic Pain</condition>
  <arm_group>
    <arm_group_label>Panax Notoginseng Powder 1g</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Panax Notoginseng Powder 1g, daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panax Notoginseng Powder 5g</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Panax Notoginseng Powder 5g,daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panax Notoginseng Powder 10g</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Panax Notoginseng Powder 10g,daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panax Notoginseng Powder 15g</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Panax Notoginseng Powder 15g,daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Celecoxib Capsule 400 mg daily</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Celecoxib Capsule 400 mg daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Panax Notoginseng Powder 1g</intervention_name>
    <arm_group_label>Panax Notoginseng Powder 1g</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Panax Notoginseng Powder 5g</intervention_name>
    <arm_group_label>Panax Notoginseng Powder 5g</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Panax Notoginseng Powder 10g</intervention_name>
    <arm_group_label>Panax Notoginseng Powder 10g</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Panax Notoginseng Powder 15g</intervention_name>
    <arm_group_label>Panax Notoginseng Powder 15g</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Celecoxib Capsule 400 mg daily</intervention_name>
    <arm_group_label>Celecoxib Capsule 400 mg daily</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  had a diagnosis of classic or definite RA&#xD;
&#xD;
          -  without conflict to the written, informed consent signed prior to the enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uncontrolled medical problems&#xD;
&#xD;
          -  organic brain syndrome&#xD;
&#xD;
          -  major psychiatric disturbances&#xD;
&#xD;
          -  major communicative disorders&#xD;
&#xD;
          -  a history of severe noncompliance&#xD;
&#xD;
          -  less than 7 years of formal education, or illiteracy&#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&#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>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>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 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>Rheumatic Diseases</mesh_term>
    <mesh_term>Musculoskeletal Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celecoxib</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/NCT02260336
org study id: PNP01RP001
nct id: NCT02260336
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the effect of Panax Notoginseng Powders on Rheumatic
      Pain.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from Baseline in McGill Pain Questionnaire (MPQ) score at 24 weeks
time frame: at 0 week, 6 weeks, 12 weeks, 24 weeks
description: This well validated questionnaire assesses pain on several dimensions including sensory pain, affective pain, and evaluative pain.
measure: Change from Baseline in Visual Analog Scale(VAS) score at 24 weeks
time frame: at 0 week, 6 weeks, 12 weeks, 24 weeks
description: This rating scale involved the selection of a point along a 10-cm line, which described pain intensity on a continuum from "no pain at all" to "pain as bad as it could be." This scale has been found to be an excellent measure of self-reported pain
arm group label: Panax Notoginseng Powder 1g
arm group type: Experimental
description: Panax Notoginseng Powder 1g, daily
arm group label: Panax Notoginseng Powder 5g
arm group type: Experimental
description: Panax Notoginseng Powder 5g,daily
arm group label: Panax Notoginseng Powder 10g
arm group type: Experimental
description: Panax Notoginseng Powder 10g,daily
arm group label: Panax Notoginseng Powder 15g
arm group type: Experimental
description: Panax Notoginseng Powder 15g,daily
arm group label: Celecoxib Capsule 400 mg daily
arm group type: Active Comparator
description: Celecoxib Capsule 400 mg daily
intervention type: Dietary Supplement
intervention name: Panax Notoginseng Powder 1g
arm group label: Panax Notoginseng Powder 1g
intervention type: Dietary Supplement
intervention name: Panax Notoginseng Powder 5g
arm group label: Panax Notoginseng Powder 5g
intervention type: Dietary Supplement
intervention name: Panax Notoginseng Powder 10g
arm group label: Panax Notoginseng Powder 10g
intervention type: Dietary Supplement
intervention name: Panax Notoginseng Powder 15g
arm group label: Panax Notoginseng Powder 15g
intervention type: Drug
intervention name: Celecoxib Capsule 400 mg daily
arm group label: Celecoxib Capsule 400 mg daily
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: Rheumatic Diseases
mesh term: Musculoskeletal Pain
mesh term: Celecoxib