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/NCT05978089</url>
    </required_header>
    <id_info>
      <org_study_id>Growful2201YXS</org_study_id>
      <nct_id>NCT05978089</nct_id>
    </id_info>
    <brief_title>Effect of Yangxinshi Tablet on Exercise Tolerance in Patients With Chronic Coronary Syndrome（MET STUDY）</brief_title>
    <official_title>Efficacy and Safety of Yangxinshi Tablet in Improving Exercise Tolerance in Patients With Chronic Coronary Syndrome(Qi Deficiency and Blood Stasis Syndrome):A Randomized, Double-blind,Placebo-parallel-controlled,Multicenter Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dongzhimen Hospital, Beijing</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dongzhimen Hospital, Beijing</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study adopted a randomized, double-blind, placebo-controlled, multicenter clinical&#xD;
        design and compared the effects of Yangxinshi tablet and placebo on exercise tolerance in&#xD;
        patients with chronic coronary syndrome (CCS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of the research is to find out if the addition of Yangxinshi tablets on the basis of&#xD;
        conventional treatment can improve exercise tolerance of patients with chronic coronary&#xD;
        syndrome (CCS), improve quality of life and mental health. A total of 120 qualified CCS&#xD;
        patients were randomly divided into two groups. In addition to conventional treatment, the&#xD;
        experimental group was given Yangxinshi tablets (3 tablets/time and 3 times/day), and the&#xD;
        control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day). The&#xD;
        treatment period was 24 weeks. The primary endpoints were metabolic equivalents (METs), and&#xD;
        peak oxygen uptake measured by cardiopulmonary exercise testing after 24 weeks of treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
    <phase>Phase 4</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>Cardiopulmonary exercise test (treadmill): (MET and peak oxygen uptake)</measure>
      <time_frame>24 weeks</time_frame>
      <description>MET=Metabolic Equivalent of Task</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>anaerobic threshold</measure>
      <time_frame>24 weeks</time_frame>
      <description>Cardiopulmonary exercise test (treadmill)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>oxygen pulse</measure>
      <time_frame>24 weeks</time_frame>
      <description>Cardiopulmonary exercise test (treadmill)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>maximal exercise ventilation</measure>
      <time_frame>24 weeks</time_frame>
      <description>Cardiopulmonary exercise test (treadmill)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>electrocardiogram (ECG)</measure>
      <time_frame>24 weeks</time_frame>
      <description>Start time and duration determined by 1-mm downward shift in the ST segment on the electrocardiogram (ECG) during the cardiopulmonary exercise test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CCS angina classification</measure>
      <time_frame>24 weeks</time_frame>
      <description>The change in Canadian Cardiovascular Society (CCS) angina scores in all participants. Scoring is via Class I-IV where class IV is worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Seattle Angina Questionnaire</measure>
      <time_frame>24 weeks</time_frame>
      <description>The Seattle Angina Questionaire (SAQ) quantifies patients'physical limitations caused by angina. The scale is transformed to a score of 0 to 100, where higher scores indicate better function (less physical limitation)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>24 weeks</time_frame>
      <description>score range: 0~21，higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General Anxiety Disorder-7 (GAD-7)</measure>
      <time_frame>24 weeks</time_frame>
      <description>score range: 0~21，higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire (PHQ-9)</measure>
      <time_frame>24 weeks</time_frame>
      <description>score range: 0-27，higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Traditional Chinese medicine (TCM) Syndrome Score</measure>
      <time_frame>24 weeks</time_frame>
      <description>the main symptoms score range: 2-6，the secondary symptoms score range: 1-3，higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospitalization within 6 months of taking the medicine</measure>
      <time_frame>24 weeks</time_frame>
      <description>total hospitalization time and hospitalization frequency</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Liver function</measure>
      <time_frame>24 weeks</time_frame>
      <description>alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (TBil), and glutamyl transferase (GGT) (γ-GT)</description>
    </other_outcome>
    <other_outcome>
      <measure>Renal function</measure>
      <time_frame>24 weeks</time_frame>
      <description>blood urea nitrogen (BUN) and serum creatinine (Scr)</description>
    </other_outcome>
    <other_outcome>
      <measure>Myocardial markers</measure>
      <time_frame>24 weeks</time_frame>
      <description>creatine kinase (CK), troponin I (TnI) (if not available, troponin T (TnT)), and N-terminal pro-B-type natriuretic peptide (NT-proBNP)</description>
    </other_outcome>
    <other_outcome>
      <measure>Blood lipids</measure>
      <time_frame>24 weeks</time_frame>
      <description>cholesterol (CHO), triglyceride (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Chronic Coronary Syndrome</condition>
    <arm_group>
      <arm_group_label>Treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Yangxinshi tablet</intervention_name>
      <description>The treatment group was given Yangxinshi tablets (3 tablets/time and 3 times/day). The treatment period was 24 weeks.</description>
      <arm_group_label>Treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Yangxinshi tablet simulants</intervention_name>
      <description>The control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day).The treatment period was 24 weeks.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          All the following criteria must be met to participate in the study:&#xD;
  &#xD;
            1. Meet the diagnostic criteria for CCS in Western medicine; stable coronary heart&#xD;
               disease (CHD) with a degree of coronary stenosis ≥50% by angiography or computed&#xD;
               tomography angiography (CTA) (including patients with more than 1 year of&#xD;
               revascularization)&#xD;
  &#xD;
            2. Meet the TCM standard of Qi deficiency and blood stasis syndrome&#xD;
  &#xD;
            3. MET &lt; 5 measured by cardiopulmonary exercise test (treadmill)&#xD;
  &#xD;
            4. Age between 18 and 75 years (including both age limits), with no limitation on sex&#xD;
  &#xD;
            5. Understanding and voluntarily signing the written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          All the following criteria must not be met to participate in the study:&#xD;
  &#xD;
            1. Individuals with lower extremity dysfunction, intermittent claudication or severe leg&#xD;
               pain who cannot participate in cardiopulmonary exercise tests&#xD;
  &#xD;
            2. Individuals with acute coronary syndrome within 1 month after percutaneous coronary&#xD;
               intervention (PCI) or within 3 months after coronary artery bypass grafting (CABG)&#xD;
  &#xD;
            3. Individuals with serious primary diseases related to the liver, kidney, and&#xD;
               hematopoietic system, acute infectious diseases, and mental illness and individuals&#xD;
               with other diseases who are not suitable for cardiopulmonary exercise tests&#xD;
  &#xD;
            4. Individuals with a revascularization plan within a month&#xD;
  &#xD;
            5. Individuals with left main stenosis ≥50% or proximal left anterior descending (LAD)&#xD;
               diameter stenosis ≥90% without PCI or CABG&#xD;
  &#xD;
            6. Individuals with absolute and relative contraindications to cardiopulmonary exercise&#xD;
               testing (please see Appendix 11 for details)&#xD;
  &#xD;
            7. Individuals with New York Heart Association (NYHA) cardiac function class III and IV&#xD;
  &#xD;
            8. Individuals with acute cerebrovascular disease&#xD;
  &#xD;
            9. Individuals with uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg and&#xD;
               diastolic blood pressure ≥ 100 mmHg&#xD;
  &#xD;
           10. Individuals found to be in a state of severe anxiety and depression as determined&#xD;
               using the GAD-7 and PHQ-9&#xD;
  &#xD;
           11. Individuals with allergies or abnormal drug reactions to the test drugs&#xD;
  &#xD;
           12. Women of childbearing age who are pregnant or breastfeeding, plan to get pregnant&#xD;
               within six months, have a positive pregnancy test, and cannot take effective&#xD;
               contraceptive measures during the study period&#xD;
  &#xD;
           13. Individuals who have regularly taken YTs, Chinese herbal decoctions or proprietary&#xD;
               Chinese medicines with similar curative effects within the past 7 days (please refer&#xD;
               to Appendix 12 for the names of proprietary Chinese medicines)&#xD;
  &#xD;
           14. Individuals who have participated in other clinical trials within the past 3 months&#xD;
  &#xD;
           15. Individuals unsuitable for the clinical trials, as determined by the researchers&#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>China-Japan Friendship Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Li Xian Lun, Professor</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Dongzhimen Hospital Beijing University of Chinese Medicine</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wang Xian, Professor</last_name>
        <phone>010-84013203</phone>
        <email>wx650515@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Chongqing Medical University</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Guangdong Provincial Hospital of Chinese Medicine</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Chen Qiu Xiong, Professor</last_name>
      </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>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Henan University of CM</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wang Yong Xia, Professor</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dongzhimen Hospital, Beijing</investigator_affiliation>
      <investigator_full_name>Wang Xian</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Cardiopulmonary Exercise Test</keyword>
    <keyword>Yangxinshi</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <!-- 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/NCT05978089
  org study id: Growful2201YXS
  nct id: NCT05978089
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study adopted a randomized, double-blind, placebo-controlled, multicenter clinical
        design and compared the effects of Yangxinshi tablet and placebo on exercise tolerance in
        patients with chronic coronary syndrome (CCS).
  The aim of the research is to find out if the addition of Yangxinshi tablets on the basis of
        conventional treatment can improve exercise tolerance of patients with chronic coronary
        syndrome (CCS), improve quality of life and mental health. A total of 120 qualified CCS
        patients were randomly divided into two groups. In addition to conventional treatment, the
        experimental group was given Yangxinshi tablets (3 tablets/time and 3 times/day), and the
        control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day). The
        treatment period was 24 weeks. The primary endpoints were metabolic equivalents (METs), and
        peak oxygen uptake measured by cardiopulmonary exercise testing after 24 weeks of treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Cardiopulmonary exercise test (treadmill): (MET and peak oxygen uptake)
  time frame: 24 weeks
  description: MET=Metabolic Equivalent of Task
  measure: anaerobic threshold
  time frame: 24 weeks
  description: Cardiopulmonary exercise test (treadmill)
  measure: oxygen pulse
  time frame: 24 weeks
  description: Cardiopulmonary exercise test (treadmill)
  measure: maximal exercise ventilation
  time frame: 24 weeks
  description: Cardiopulmonary exercise test (treadmill)
  measure: electrocardiogram (ECG)
  time frame: 24 weeks
  description: Start time and duration determined by 1-mm downward shift in the ST segment on the electrocardiogram (ECG) during the cardiopulmonary exercise test
  measure: CCS angina classification
  time frame: 24 weeks
  description: The change in Canadian Cardiovascular Society (CCS) angina scores in all participants. Scoring is via Class I-IV where class IV is worse outcome.
  measure: Seattle Angina Questionnaire
  time frame: 24 weeks
  description: The Seattle Angina Questionaire (SAQ) quantifies patients'physical limitations caused by angina. The scale is transformed to a score of 0 to 100, where higher scores indicate better function (less physical limitation)
  measure: Pittsburgh Sleep Quality Index (PSQI)
  time frame: 24 weeks
  description: score range: 0~21，higher scores mean a worse outcome.
  measure: General Anxiety Disorder-7 (GAD-7)
  time frame: 24 weeks
  description: score range: 0~21，higher scores mean a worse outcome.
  measure: Patient Health Questionnaire (PHQ-9)
  time frame: 24 weeks
  description: score range: 0-27，higher scores mean a worse outcome.
  measure: Traditional Chinese medicine (TCM) Syndrome Score
  time frame: 24 weeks
  description: the main symptoms score range: 2-6，the secondary symptoms score range: 1-3，higher scores mean a worse outcome.
  measure: Hospitalization within 6 months of taking the medicine
  time frame: 24 weeks
  description: total hospitalization time and hospitalization frequency
  measure: Liver function
  time frame: 24 weeks
  description: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (TBil), and glutamyl transferase (GGT) (γ-GT)
  measure: Renal function
  time frame: 24 weeks
  description: blood urea nitrogen (BUN) and serum creatinine (Scr)
  measure: Myocardial markers
  time frame: 24 weeks
  description: creatine kinase (CK), troponin I (TnI) (if not available, troponin T (TnT)), and N-terminal pro-B-type natriuretic peptide (NT-proBNP)
  measure: Blood lipids
  time frame: 24 weeks
  description: cholesterol (CHO), triglyceride (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL)
  arm group label: Treatment group
  arm group type: Experimental
  arm group label: Control group
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Yangxinshi tablet
  description: The treatment group was given Yangxinshi tablets (3 tablets/time and 3 times/day). The treatment period was 24 weeks.
  arm group label: Treatment group
  intervention type: Drug
  intervention name: Yangxinshi tablet simulants
  description: The control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day).The treatment period was 24 weeks.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  facility: 
  contact: 
  facility: 
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Dongzhimen Hospital, Beijing
  investigator full name: Wang Xian
  investigator title: Professor
  mesh term: Syndrome