Short-term Effects of Passiflora and Meditation on Blood Pressure and Heart Rate

University of Bridgeport

Status: Unknown

Conditions: Heart Rate Fast; Blood Pressure

Treatments: Dietary Supplement: Passiflora incarnata

Study type: Interventional

Funder types: Other

Identifiers

NCT03953469

2019-02-01

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: all University of Bridgeport students are invited to participate

Exclusion Criteria:

1. Those taking hypertensive medication
2. Those taking anti-anxiety medication, including MAOI medication
3. Those taking blood-thinning medication
4. Those who are pregnant
5. Those who could be pregnant
6. Those who will have surgery 2 weeks before the research date
7. Those who are scheduled to have surgery 2 weeks after the research date
8. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 2 patient groups

Placebo Group

No Intervention group

Description:

(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 group

Description:

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.

Treatment:

Dietary Supplement: Passiflora incarnata