Heart Rate FastNCT03953469
Short-term Effects of Passiflora and Meditation on Blood Pressure and Heart Rate
A study testing Passiflora incarnata in people with Heart Rate Fast and Blood Pressure, run by University of Bridgeport.
Trial summary
This study is intended to study the effects of one-time acute dosing of a solid extract of Passiflora incarnata, also known as Passionflower, on blood pressure and heart rate in students. Our hypothesis is that blood pressure levels and heart rates will decrease significantly in response to Passiflora incarnata. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Fast, Blood Pressure
- What is being tested?
- Passiflora incarnata
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Those taking hypertensive medication
- Those taking anti-anxiety medication, including MAOI medication
- Those taking blood-thinning medication
- Those who are pregnant
- Those who could be pregnant
- Those who will have surgery 2 weeks before the research date
- Those who are scheduled to have surgery 2 weeks after the research date
- Those who have consumed caffeine, food/tyramine containing foods, stimulant medication, cold medicine, decongestant medicine, antihistamine medicine, cough suppressants, alcoholic beverages, or stimulant energy drinks within 2 hours before the study period.
Trial locations and contacts
No sites are listed yet.
Mark Mattie, MD, PhD contact
About this study
Official title: Investigating the Short-term Effects of Passiflora Incarnate and Mobile Audio-guided Meditation on Blood Pressure and Heart Rate in Naturopathic Medical Students
This study is intended to study the effects of one-time acute dosing of a solid extract of Passiflora incarnata, also known as Passionflower, on blood pressure and heart rate in students. Our hypothesis is that blood pressure levels and heart rates will decrease significantly in response to Passiflora incarnata.
- Conditions
- Heart Rate Fast, Blood Pressure
- Being tested
- Passiflora incarnata
- Keywords
- passionflower, heart rate, blood pressure
- Medical subject headings
- Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passiflora incarnataDietary supplement
Also called Passionflower
One-time administration of 1/8 tsp solid extract Passiflora incarnata providing 900mg of Passiflora incarnata
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | No intervention | (a) Baseline blood pressure readings and one heart rate reading taken after at least 5 minutes of rest time without talking, eating, or caffeine consumption. b) will be given 1/4 tsp of blackstrap molasses placebo. Subjects may not consume caffeine or eat food during this time. (c) blood pressure readings and one heart rate will be taken 15 minutes after the baseline reading. |
| Group II | Active comparator | 1. Baseline blood pressure readings and one heart rate reading taken after at least 5 minutes of rest time without talking, eating food, or caffeine consumption.
2. 15 minutes after examination - will be given 1/8 tsp (900mg) of Passiflora incarnata solid extract by Wise Woman Herbals mixed with 1/8 tsp of blackstrap molasses to mask the taste.
3. blood pressure readings and one heart rate will be taken 15 minutes after the baseline reading. Receives: Dietary Supplement: Passiflora incarnata |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure between baseline and 15 minutes
Change in blood pressure between baseline and 15 minutes
Measured: 15 minutes
Change in heart rate between baseline and 15 minutes
Change in heart rate between baseline and 15 minutes
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study startAug 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate FastStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bridgeport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Sanders, University of Bridgeport
- Investigators
- Kimberly Sanders, ND, Principal investigator, University of Bridgeport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953469
- Sponsor's protocol ID
- 2019-02-01
- Status last verified
- Mar 2020
- First submitted
- 9 May 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Short-term Effects of Passiflora Incarnate and Mobile Audio-guided Meditation on Blood Pressure and Heart Rate in Naturopathic Medical Students
- ClinicalTrials.gov ID
- NCT03953469
- Acronym / sponsor ID
- 2019-02-01
- Conditions
- Heart Rate Fast, Blood Pressure
- Keywords
- passionflower, heart rate, blood pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of BridgeportUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to study the effects of one-time acute dosing of a solid extract of Passiflora incarnata, also known as Passionflower, on blood pressure and heart rate in students. Our hypothesis is that blood pressure levels and heart rates will decrease significantly in response to Passiflora incarnata.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | No intervention | –(a) Baseline blood pressure readings and one heart rate reading taken after at least 5 minutes of rest time without talking, eating, or caffeine consumption. b) will be given 1/4 tsp of blackstrap molasses placebo. Subjects may not consume caffeine or eat food during this time. (c) blood pressure readings and one heart rate will be taken 15 minutes after the baseline reading. |
| Group II | Active comparator | Dietary Supplement: Passiflora incarnata1. Baseline blood pressure readings and one heart rate reading taken after at least 5 minutes of rest time without talking, eating food, or caffeine consumption. 2. 15 minutes after examination - will be given 1/8 tsp (900mg) of Passiflora incarnata solid extract by Wise Woman Herbals mixed with 1/8 tsp of blackstrap molasses to mask the taste. 3. blood pressure readings and one heart rate will be taken 15 minutes after the baseline reading. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Those taking hypertensive medication
- Those taking anti-anxiety medication, including MAOI medication
- Those taking blood-thinning medication
- Those who are pregnant
- Those who could be pregnant
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 |
|---|---|---|
| Passiflora incarnataAlso: PassionflowerOne-time administration of 1/8 tsp solid extract Passiflora incarnata providing 900mg of Passiflora incarnata | Dietary supplement | Group II |
Primary outcome
Change in blood pressure between baseline and 15 minutes
Time frame: 15 minutes
Change in blood pressure between baseline and 15 minutes
Change in heart rate between baseline and 15 minutes
Time frame: 15 minutes
Change in heart rate between baseline and 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Mark Mattie, MD, PhD contact
Kimberly Sanders, ND principal investigator
University of Bridgeport
Questions about this trial
What is this clinical trial studying?
A study testing Passiflora incarnata in people with Heart Rate Fast and Blood Pressure, run by University of Bridgeport.
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 0 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Sanders, ND (2035764425, kimbersa@bridgeport.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure between baseline and 15 minutes (time frame: 15 minutes). The study lists 2 primary outcomes in all. 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 26 Mar 2020.