<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/NCT02228343</url>
  </required_header>
  <id_info>
    <org_study_id>UNM2013.1</org_study_id>
    <nct_id>NCT02228343</nct_id>
  </id_info>
  <brief_title>A Prospective Trial of Ayurveda for Coronary Artery Disease</brief_title>
  <official_title>A Prospective Trial of Ayurveda for Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ayurvedic Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of New Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Can Ayurvedic therapy improve markers of cardiovascular health and cardiovascular risk&#xD;
      factors in patients with coronary artery disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with established coronary artery disease will be treated with 90 days of Ayurvedic&#xD;
      therapy to include yoga, meditation, breathing exercises,and herbs. Arterial stiffness,&#xD;
      weight, BMI, BP, medications, cholesterol, LDL, HDL, triglyceride, HS-CRP will be measured at&#xD;
      baseline and after 90 days of therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Arterial stiffness, measured as pulse wave velocity meters/second</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body mass index (BMI)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure in mm Hg</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol in mg/dl</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL cholesterol in mg/dl</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL cholesterol in mg/dl</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglyceride in mg/dl</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Ayurveda</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ayurvedic therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ayurveda</intervention_name>
    <description>Ayurveda includes meditation, yoga, breathing exercises, herbs</description>
    <arm_group_label>Ayurveda</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stable coronary artery disease (prior mi, coronary angioplasty or stent, coronary&#xD;
             bypass surgery)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  life expectancy &lt; 6 months&#xD;
&#xD;
          -  pregnancy or breast feeding&#xD;
&#xD;
          -  unwilling or unable to complete 90 days of therapy&#xD;
&#xD;
          -  already receiving/taking Ayurvedic therapy&#xD;
&#xD;
          -  unable to converse in or understand English language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert J DuBroff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New Mexico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of New Mexico Medical Group McMahon Cardiology</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Mexico</investigator_affiliation>
    <investigator_full_name>Robert DuBroff</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>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</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/NCT02228343
org study id: UNM2013.1
nct id: NCT02228343
lead sponsor: 
collaborator: 
has dmc: No
Can Ayurvedic therapy improve markers of cardiovascular health and cardiovascular risk
      factors in patients with coronary artery disease.
Patients with established coronary artery disease will be treated with 90 days of Ayurvedic
      therapy to include yoga, meditation, breathing exercises,and herbs. Arterial stiffness,
      weight, BMI, BP, medications, cholesterol, LDL, HDL, triglyceride, HS-CRP will be measured at
      baseline and after 90 days of therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Arterial stiffness, measured as pulse wave velocity meters/second
time frame: 3 months
measure: Body mass index (BMI)
time frame: 3 months
measure: Blood pressure in mm Hg
time frame: 3 months
measure: Total cholesterol in mg/dl
time frame: 3 months
measure: LDL cholesterol in mg/dl
time frame: 3 months
measure: HDL cholesterol in mg/dl
time frame: 3 months
measure: Triglyceride in mg/dl
time frame: 3 months
arm group label: Ayurveda
arm group type: Experimental
description: Ayurvedic therapy
intervention type: Other
intervention name: Ayurveda
description: Ayurveda includes meditation, yoga, breathing exercises, herbs
arm group label: Ayurveda
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert J DuBroff, MD
role: Principal Investigator
affiliation: University of New Mexico
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of New Mexico
investigator full name: Robert DuBroff
investigator title: Principal Investigator
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease