Coronary Artery DiseaseNCT02228343
A Prospective Trial of Ayurveda for Coronary Artery Disease
A study testing Ayurveda in people with Coronary Artery Disease, run by University of New Mexico at 1 site in United States.
Trial summary
Can Ayurvedic therapy improve markers of cardiovascular health and cardiovascular risk factors in patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ayurveda
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- stable coronary artery disease (prior mi, coronary angioplasty or stent, coronary bypass surgery)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Medical Group McMahon Cardiology
Albuquerque, New Mexico, 87114
About this study
Can Ayurvedic therapy improve markers of cardiovascular health and cardiovascular risk factors in patients with coronary artery disease.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Ayurveda
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AyurvedaOther
Ayurveda includes meditation, yoga, breathing exercises, herbs
| Study group | Role | What they receive |
|---|---|---|
| Ayurveda | Experimental | Ayurvedic therapy Receives: Other: Ayurveda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Arterial Stiffness Were Measured as Pulse Wave Velocity Meters/Second
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert DuBroff, University of New Mexico
- Investigators
- Robert J DuBroff, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228343
- Sponsor's protocol ID
- UNM2013.1
- Status last verified
- Feb 2024
- First submitted
- 21 Aug 2014
- Last updated
- 1 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of Ayurveda for Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02228343
- Acronym / sponsor ID
- UNM2013.1
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Posted 1 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ayurveda | Experimental | Other: AyurvedaAyurvedic therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- stable coronary artery disease (prior mi, coronary angioplasty or stent, coronary bypass surgery)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AyurvedaAyurveda includes meditation, yoga, breathing exercises, herbs | Other | Ayurveda |
Primary outcome
Participants With Arterial Stiffness Were Measured as Pulse Wave Velocity Meters/Second
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J DuBroff, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ayurveda in people with Coronary Artery Disease, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Arterial Stiffness Were Measured as Pulse Wave Velocity Meters/Second (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.