Back to resultsA Prospective Trial of Ayurveda for Coronary Artery Disease
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ayurveda
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- stable coronary artery disease (prior mi, coronary angioplasty or stent, coronary bypass surgery)
Exclusion Criteria:
- age < 18 years
- life expectancy < 6 months
- pregnancy or breast feeding
- unwilling or unable to complete 90 days of therapy
- already receiving/taking Ayurvedic therapy
- unable to converse in or understand English language
Sites / Locations
- University of New Mexico Medical Group McMahon Cardiology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ayurveda
Arm Description
Ayurvedic therapy
Outcomes
Primary Outcome Measures
Arterial stiffness, measured as pulse wave velocity meters/second
Secondary Outcome Measures
Body mass index (BMI)
Blood pressure in mm Hg
Total cholesterol in mg/dl
LDL cholesterol in mg/dl
HDL cholesterol in mg/dl
Triglyceride in mg/dl
Full Information
NCT ID
NCT02228343
First Posted
August 21, 2014
Last Updated
October 11, 2023
Sponsor
University of New Mexico
1. Study Identification
Unique Protocol Identification Number
NCT02228343
Brief Title
A Prospective Trial of Ayurveda for Coronary Artery Disease
Official Title
A Prospective Trial of Ayurveda for Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Can Ayurvedic therapy improve markers of cardiovascular health and cardiovascular risk factors in patients with coronary artery disease.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ayurveda
Arm Type
Experimental
Arm Description
Ayurvedic therapy
Intervention Type
Other
Intervention Name(s)
Ayurveda
Intervention Description
Ayurveda includes meditation, yoga, breathing exercises, herbs
Primary Outcome Measure Information:
Title
Arterial stiffness, measured as pulse wave velocity meters/second
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Body mass index (BMI)
Time Frame
3 months
Title
Blood pressure in mm Hg
Time Frame
3 months
Title
Total cholesterol in mg/dl
Time Frame
3 months
Title
LDL cholesterol in mg/dl
Time Frame
3 months
Title
HDL cholesterol in mg/dl
Time Frame
3 months
Title
Triglyceride in mg/dl
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stable coronary artery disease (prior mi, coronary angioplasty or stent, coronary bypass surgery)
Exclusion Criteria:
age < 18 years
life expectancy < 6 months
pregnancy or breast feeding
unwilling or unable to complete 90 days of therapy
already receiving/taking Ayurvedic therapy
unable to converse in or understand English language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J DuBroff, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico Medical Group McMahon Cardiology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Prospective Trial of Ayurveda for Coronary Artery Disease
We'll reach out to this number within 24 hrs