<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/NCT04505228</url>
  </required_header>
  <id_info>
    <org_study_id>qdms17337nsh</org_study_id>
    <nct_id>NCT04505228</nct_id>
  </id_info>
  <brief_title>The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia</brief_title>
  <official_title>The Personalized Chinese Herb Formulas Are Evaluated for Their Effectiveness to Relieve Symptoms in Hypertensive Bradyarrhythmia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jun Xiao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Qingdao Fifth People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Macrohard Institute of Health</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>
      72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and&#xD;
      randomly divided into research group and control group. The research group received regular&#xD;
      medication against hypertension and the personalized formulas based on syndrome&#xD;
      differentiation, meanwhile the control group only received the regular medication. The five&#xD;
      symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded and&#xD;
      used for evaluation of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To test the effect of Chinese herb against the hypertensive heart disease, we designed this&#xD;
      randomized controlled clinical trial. 72 patients who have been diagnosed with hypertensive&#xD;
      bradyarrhythmia were selected and randomly divided into research group and control group. The&#xD;
      five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded.&#xD;
      The research group received regular medication against hypertension and the personalized&#xD;
      formulas based on syndrome differentiation, meanwhile the control group only received the&#xD;
      regular medication. 2 weeks after treatment, all the symptoms were graded again.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2020</start_date>
  <completion_date type="Actual">June 20, 2020</completion_date>
  <primary_completion_date type="Actual">March 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>typical symptoms in patients with hypertensive bradyarrhythmia</measure>
    <time_frame>2 weeks</time_frame>
    <description>The five indexes of typical symptoms in patients with hypertensive bradyarrhythmia (palpitation, angina, shortness of breath, dizzy, lumbar debility) were evaluated and scored both before treatment and after treatment according to &quot;Guiding principles for clinical research of new Chinese Medicine&quot;.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Hypertensive Heart Disease</condition>
  <arm_group>
    <arm_group_label>Research group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients receiving Atropine and the extra Chinese herb formulas treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients receiving the basic treatment of atropine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Safflower (Carthamus Tinctorius) IgG4 &amp;#X7C; Serum &amp;#X7C; Allergy</intervention_name>
    <description>The designed Chinese herb formulas</description>
    <arm_group_label>Research group</arm_group_label>
    <other_name>Xuefuzhuyu</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atropine Sulfate</intervention_name>
    <description>The basic treatment for heart disease</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Research group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        * Clinical diagnosis of hypertensive bradyarhhythmia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With other elementary diseases&#xD;
&#xD;
          -  With pregnant&#xD;
&#xD;
          -  With receiving other treatment within past half year from the beginning of trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The fifth Qingdao people's hospital</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Macrohard Institute of Health</investigator_affiliation>
    <investigator_full_name>Jun Xiao</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Bradycardia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atropine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04505228
org study id: qdms17337nsh
nct id: NCT04505228
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and
      randomly divided into research group and control group. The research group received regular
      medication against hypertension and the personalized formulas based on syndrome
      differentiation, meanwhile the control group only received the regular medication. The five
      symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded and
      used for evaluation of treatment.
To test the effect of Chinese herb against the hypertensive heart disease, we designed this
      randomized controlled clinical trial. 72 patients who have been diagnosed with hypertensive
      bradyarrhythmia were selected and randomly divided into research group and control group. The
      five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded.
      The research group received regular medication against hypertension and the personalized
      formulas based on syndrome differentiation, meanwhile the control group only received the
      regular medication. 2 weeks after treatment, all the symptoms were graded again.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: typical symptoms in patients with hypertensive bradyarrhythmia
time frame: 2 weeks
description: The five indexes of typical symptoms in patients with hypertensive bradyarrhythmia (palpitation, angina, shortness of breath, dizzy, lumbar debility) were evaluated and scored both before treatment and after treatment according to "Guiding principles for clinical research of new Chinese Medicine".
arm group label: Research group
arm group type: Experimental
description: The patients receiving Atropine and the extra Chinese herb formulas treatment
arm group label: Control group
arm group type: Active Comparator
description: The patients receiving the basic treatment of atropine
intervention type: Drug
intervention name: Safflower (Carthamus Tinctorius) IgG4 &#X7C; Serum &#X7C; Allergy
description: The designed Chinese herb formulas
arm group label: Research group
other name: Xuefuzhuyu
intervention type: Drug
intervention name: Atropine Sulfate
description: The basic treatment for heart disease
arm group label: Control group
arm group label: Research group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Macrohard Institute of Health
investigator full name: Jun Xiao
investigator title: Principal Investigator
mesh term: Heart Diseases
mesh term: Bradycardia
mesh term: Atropine
sharing ipd: Undecided