xml: <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/NCT06000956</url>
    </required_header>
    <id_info>
      <org_study_id>TSL-TCM-JTNP-Ⅲ</org_study_id>
      <nct_id>NCT06000956</nct_id>
    </id_info>
    <brief_title>A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo</brief_title>
    <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Protocol of the Efficacy and Safety of Jitongning Tablets for Treating Spondyloarthritis (Kidney Yang Deficiency and Blood Stasis Obstruction)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tasly Pharmaceutical Group Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tasly Pharmaceutical Group Co., Ltd</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is evaluating the efficacy and safety of Jitongning tablets&#xD;
        in participant population. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Based on the proportion of participants who achieved improvement in ASAS20, evaluate&#xD;
             whether the efficacy of Jitongning tablets is superior to placebo in active ax-SpA adult&#xD;
             participants.&#xD;
  &#xD;
          -  Evaluate the efficacy of Jitongning tablets in improving other key functions and symptom&#xD;
             outcomes.&#xD;
  &#xD;
          -  Evaluating the safety of Jitongning tablets in adult ax-SpA participants. Participants&#xD;
             will&#xD;
  &#xD;
               1. take orally Jitongning tablets or a simulated agent of Jitongning tablets.&#xD;
  &#xD;
               2. Receive examinations and follow-up visits.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">August 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 15, 2025</primary_completion_date>
    <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>ASAS20</measure>
      <time_frame>8 weeks</time_frame>
      <description>Proportion of subjects who achieved improvement in ASAS20 at week 8 of treatment.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">408</enrollment>
    <condition>Ankylosing Spondylitis</condition>
    <arm_group>
      <arm_group_label>Jitongning tablets</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>a simulated agent of Jitongning tablets</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Jitongning tablets</intervention_name>
      <description>The participants took orally three tablets of Jitongning tablets, twice a day, for 8 consecutive weeks.</description>
      <arm_group_label>Jitongning tablets</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>a simulated agent of Jitongning tablets</intervention_name>
      <description>The participants took orally three tablets of a simulated agent of Jitongning tablets, twice a day, for 8 consecutive weeks.</description>
      <arm_group_label>a simulated agent of Jitongning tablets</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          All of the following standards must be met:&#xD;
  &#xD;
            1. Age range from 18 to 65 years old (including 18 and 65 years old), regardless of&#xD;
               gender;&#xD;
  &#xD;
            2. Meets the diagnostic criteria for axial osteoarthritis recommended by ASAS in 2009,&#xD;
               and the condition is in an active phase. The criteria for determining disease activity&#xD;
               are to meet two criteria: Bass ankylosing spondylitis disease activity index (BASDAI)&#xD;
               ≥ 40mm (0-100mm, evaluated using VAS); Spinal pain score ≥ 40mm (0-100mm, evaluated&#xD;
               using VAS);&#xD;
  &#xD;
            3. Conforming to the traditional Chinese medicine syndrome differentiation standards for&#xD;
               kidney yang deficiency and blood stasis obstruction syndrome;&#xD;
  &#xD;
            4. CT examination of sacroiliac arthritis grades I (A) to II (B) (both included);&#xD;
  &#xD;
            5. Human leukocyte antigen B27 (HLA-B27) is positive;&#xD;
  &#xD;
            6. Elevated C-reactive protein (CRP)/hypersensitive C-reactive protein (hsCRP) and/or&#xD;
               erythrocyte sedimentation rate (ESR);&#xD;
  &#xD;
            7. Voluntarily participate in this clinical trial and sign an informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Those who meet any of the following criteria cannot be included in this experiment:&#xD;
  &#xD;
            1. Received non-steroidal anti-inflammatory drugs within 2 weeks before enrollment;&#xD;
  &#xD;
            2. Within 4 weeks before enrollment, he received traditional Chinese patent medicines and&#xD;
               simple preparations or traditional Chinese medicine decoction, chemical drugs (such as&#xD;
               sulfasalazine, methotrexate, leflunomide, hydroxychloroquine, cyclophosphamide,&#xD;
               azathioprine, etc.), opioid analgesics (such as methadone, morphine, etc.), JAK&#xD;
               inhibitor drugs (such as tofatib, etc.), and systemic glucocorticoid treatment;&#xD;
  &#xD;
            3. Received spinal or joint surgery treatment within 8 weeks prior to enrollment;&#xD;
  &#xD;
            4. Within 12 weeks prior to enrollment, biological agents with therapeutic effects on&#xD;
               spinal arthritis have been used;&#xD;
  &#xD;
            5. Within 6 months prior to enrollment, corticosteroid injections were received into the&#xD;
               joint cavity or spine/paravertebral area;&#xD;
  &#xD;
            6. CT indicates disappearance of sacroiliac joint space or complete spinal rigidity;&#xD;
  &#xD;
            7. Subjects diagnosed with other rheumatic immune system diseases or immune deficiency&#xD;
               syndrome, such as active ulcerative colitis, psoriasis, uveitis, etc;&#xD;
  &#xD;
            8. Those who have fertility requirements within six months;&#xD;
  &#xD;
            9. Pregnant or lactating women;&#xD;
  &#xD;
           10. Suspected or actual drug, substance, or alcohol abuse;&#xD;
  &#xD;
           11. Within 3 months prior to the trial or currently participating in clinical trials;&#xD;
  &#xD;
           12. Serious heart, liver, kidney, brain, mental, and neurological disorders that affect&#xD;
               informed consent and/or expression or observation of adverse events;&#xD;
  &#xD;
           13. Abnormal liver function (elevated levels of alanine or alanine aminotransferase above&#xD;
               the upper limit of normal values); Abnormal renal function (serum creatinine levels&#xD;
               above the upper limit of normal values);&#xD;
  &#xD;
           14. The researchers believe that it is not suitable to participate in this experiment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Wei Liu</last_name>
      <phone>022-27432680</phone>
      <email>fengshiliuwei@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Dongfang Hospital, Beijing University of Chinese Medicine</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100078</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wenna Liu</last_name>
        <phone>010-67689923</phone>
        <email>dfjgb2019@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Beijing Hospital of Traditional Chinese Medicine, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xueqi Zhu</last_name>
        <phone>010-52176813</phone>
        <email>bjzyyygcp@sina.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Hospital of Lanzhou University</name>
        <address>
          <city>Lanzhou</city>
          <state>Gansu</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ting Wang</last_name>
        <phone>0931-8356748</phone>
        <email>ting_w6710@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Hospital of Hebei Medical University</name>
        <address>
          <city>Shijiazhuang</city>
          <state>Hebei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wenxiu Si</last_name>
        <phone>0311-87156671</phone>
        <email>swxlbc@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Henan University of Science and Technology</name>
        <address>
          <city>Luoyang</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yuntong Zhai</last_name>
        <phone>0379-64830815</phone>
        <email>1652065260@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chang Shu</last_name>
        <phone>027-83663940</phone>
        <email>tongjigcp@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Suzhou Hospital of Traditional Chinese Medicine</name>
        <address>
          <city>Suzhou</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaofeng Zhu</last_name>
        <phone>0512-67872186</phone>
        <email>szszyyyll@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Affiliated Hospital of North Sichuan Medical College</name>
        <address>
          <city>Nanchong</city>
          <state>Sichuan</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yan Zeng</last_name>
        <phone>0817-2608120</phone>
        <email>393241992@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hui Wang</last_name>
        <phone>022-27986257</phone>
        <email>yfyjdb@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Yunnan Province Hospital of Traditional Chinese Medicine</name>
        <address>
          <city>Kunming</city>
          <state>Yunnan</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>An Wang</last_name>
        <phone>0871-63623713</phone>
        <email>ynzygcp1@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spondylitis</mesh_term>
      <mesh_term>Spondylarthritis</mesh_term>
      <mesh_term>Spondylitis, Ankylosing</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000956
  org study id: TSL-TCM-JTNP-Ⅲ
  nct id: NCT06000956
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is evaluating the efficacy and safety of Jitongning tablets
        in participant population. The main questions it aims to answer are:
  
          -  Based on the proportion of participants who achieved improvement in ASAS20, evaluate
             whether the efficacy of Jitongning tablets is superior to placebo in active ax-SpA adult
             participants.
  
          -  Evaluate the efficacy of Jitongning tablets in improving other key functions and symptom
             outcomes.
  
          -  Evaluating the safety of Jitongning tablets in adult ax-SpA participants. Participants
             will
  
               1. take orally Jitongning tablets or a simulated agent of Jitongning tablets.
  
               2. Receive examinations and follow-up visits.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: ASAS20
  time frame: 8 weeks
  description: Proportion of subjects who achieved improvement in ASAS20 at week 8 of treatment.
  arm group label: Jitongning tablets
  arm group type: Experimental
  arm group label: a simulated agent of Jitongning tablets
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Jitongning tablets
  description: The participants took orally three tablets of Jitongning tablets, twice a day, for 8 consecutive weeks.
  arm group label: Jitongning tablets
  intervention type: Drug
  intervention name: a simulated agent of Jitongning tablets
  description: The participants took orally three tablets of a simulated agent of Jitongning tablets, twice a day, for 8 consecutive weeks.
  arm group label: a simulated agent of Jitongning tablets
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Wei Liu
  phone: 022-27432680
  email: fengshiliuwei@163.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Spondylitis
  mesh term: Spondylarthritis
  mesh term: Spondylitis, Ankylosing
  sharing ipd: No