<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/NCT04421287</url>
  </required_header>
  <id_info>
    <org_study_id>2020XLA018-2</org_study_id>
    <nct_id>NCT04421287</nct_id>
  </id_info>
  <brief_title>Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With SCAD</brief_title>
  <official_title>Clinical Study on the Effect of Zhenyuan Capsule on Cardiopulmonary Function in Patients With Stable Coronary Heart Disease With Qi Deficiency and Blood Stasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiyuan Hospital of China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xiyuan Hospital of China Academy of Chinese Medical Sciences</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>
      A randomized, double-blind, placebo trial was adopted, and cardiopulmonary exercise load test&#xD;
      (CPET) was used to detect peak oxygen uptake (PeakVO2) and exercise metabolic equivalent&#xD;
      (METs) to confirm the clinical effect of Zhenyuan capsule on improving cardiopulmonary&#xD;
      endurance in patients with coronary heart disease of qi deficiency and blood stasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</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>
    <masking_description>Double mind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiopulmonary function index change</measure>
    <time_frame>Change from Baseline VO2 peak at 12 weeks / 16 weeks after drug treatment;</time_frame>
    <description>Peak Oxygen Uptake（Peak VO2）；Heart rate、Stroke volume and arteriovenous oxygen difference will be combined to report VO2 peak in mL/kg/min(milliliters of oxygen per kilogram of body weight per minute )；</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Stable Coronary Heart Disease</condition>
  <arm_group>
    <arm_group_label>Zhenyuan capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Zhenyuan capsule placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zhenyuan capsule</intervention_name>
    <description>0.25g/ tablets, 2 tablets / TID, for 12 weeks</description>
    <arm_group_label>Zhenyuan capsule</arm_group_label>
    <arm_group_label>Zhenyuan capsule placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Results of coronary angiography or spiral CT:Patients with coronary artery stenosis ≥&#xD;
             50%, or with a clear history of myocardial infarction, or stable condition more than&#xD;
             one month after ACS treatment (percutaneous coronary intervention therapy, PCI,&#xD;
             coronary artery bypass graft, CABG)；&#xD;
&#xD;
          -  LVEF≥40%；&#xD;
&#xD;
          -  Angina grade Ⅰ-Ⅱ (CCS grade);&#xD;
&#xD;
          -  The syndrome differentiation of traditional Chinese medicine is the syndrome of qi&#xD;
             deficiency and blood stasis；&#xD;
&#xD;
          -  18 years old ≤ age ≤ 75 years old；&#xD;
&#xD;
          -  In accordance with the risk stratification of cardiac rehabilitation in patients with&#xD;
             coronary heart disease, the patients with moderate and low risk can carry out&#xD;
             cardiopulmonary rehabilitation by exercise；&#xD;
&#xD;
          -  Those who sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with acute myocardial infarction or unstable angina pectoris, or within one&#xD;
             month after PCI or CABG;&#xD;
&#xD;
          -  Patients with absolute and relative contraindications in accordance with&#xD;
             cardiopulmonary exercise test;&#xD;
&#xD;
          -  Patients who took Zhenyuan capsule in the past 1 month or participated in other&#xD;
             clinical trials in the past 1 month；&#xD;
&#xD;
          -  Renal insufficiency, serum creatinine &gt; 2.5mg / dl in male and &gt; 2.0mg/dl in female；&#xD;
&#xD;
          -  Patients with obvious liver disease or both ALT and AST were 3 times higher than the&#xD;
             normal upper limit；&#xD;
&#xD;
          -  New York heart function (NYHA) grade IV, or patients with recurrent malignant&#xD;
             arrhythmias;&#xD;
&#xD;
          -  Complicated with chronic obstructive pulmonary disease or even respiratory failure, or&#xD;
             complicated with pulmonary infection;&#xD;
&#xD;
          -  Diabetic patients with random blood glucose ≥ 13.7mmol/L or glycosylated hemoglobin ≥&#xD;
             9.5%;&#xD;
&#xD;
          -  Pregnant or preparing pregnant women, lactating women;&#xD;
&#xD;
          -  Patients with acute cerebrovascular diseases; malignant tumors or patients with life&#xD;
             expectancy of less than 1 year; patients with severe hematopoietic diseases; patients&#xD;
             with severe mental illness;&#xD;
&#xD;
          -  For those who are allergic to the known ingredients of the drug.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Long C Wang, doctorate</last_name>
    <role>Study Chair</role>
    <affiliation>Xiyaun Hospital of China Academy of Chinese Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>NA HUAN, Master</last_name>
    <phone>0086</phone>
    <phone_ext>18353214796</phone_ext>
    <email>HUANNA0323@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xiyuan Hospital of China Academy of Chinese Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <zip>100091</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>long C Wang, doctorate</last_name>
      <phone>0086-010-6287</phone>
      <phone_ext>9814</phone_ext>
      <email>WCL796@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</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>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_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/NCT04421287
org study id: 2020XLA018-2
nct id: NCT04421287
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A randomized, double-blind, placebo trial was adopted, and cardiopulmonary exercise load test
      (CPET) was used to detect peak oxygen uptake (PeakVO2) and exercise metabolic equivalent
      (METs) to confirm the clinical effect of Zhenyuan capsule on improving cardiopulmonary
      endurance in patients with coronary heart disease of qi deficiency and blood stasis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double mind
measure: Cardiopulmonary function index change
time frame: Change from Baseline VO2 peak at 12 weeks / 16 weeks after drug treatment;
description: Peak Oxygen Uptake（Peak VO2）；Heart rate、Stroke volume and arteriovenous oxygen difference will be combined to report VO2 peak in mL/kg/min(milliliters of oxygen per kilogram of body weight per minute )；
arm group label: Zhenyuan capsule
arm group type: Experimental
arm group label: Zhenyuan capsule placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Zhenyuan capsule
description: 0.25g/ tablets, 2 tablets / TID, for 12 weeks
arm group label: Zhenyuan capsule
arm group label: Zhenyuan capsule placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Long C Wang, doctorate
role: Study Chair
affiliation: Xiyaun Hospital of China Academy of Chinese Medical Sciences
last name: NA HUAN, Master
phone: 0086
phone ext: 18353214796
email: HUANNA0323@163.com
facility: 
contact: 
country: China
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia