Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT03953469
Status:
UNKNOWN
Last Update Posted:
2020-03-26
First Post:
2019-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short-term Effects of Passiflora and Meditation on Blood Pressure and Heart Rate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013610', 'term': 'Tachycardia'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-28', 'size': 310896, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-14T12:06', 'hasProtocol': True}, {'date': '2019-03-28', 'size': 666167, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-05-14T12:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'There are two arms. One arm involves consuming a placebo. The second arm involves taking the Passionflower. Neither the primary investigator nor the participant will know which treatment they are taking.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2019-05-09', 'studyFirstSubmitQcDate': '2019-05-15', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood pressure between baseline and 15 minutes', 'timeFrame': '15 minutes', 'description': 'Change in blood pressure between baseline and 15 minutes'}, {'measure': 'Change in heart rate between baseline and 15 minutes', 'timeFrame': '15 minutes', 'description': 'Change in heart rate between baseline and 15 minutes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['passionflower', 'heart rate', 'blood pressure'], 'conditions': ['Heart Rate Fast', 'Blood Pressure']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: all University of Bridgeport students are invited to participate\n\nExclusion Criteria:\n\n1. Those taking hypertensive medication\n2. Those taking anti-anxiety medication, including MAOI medication\n3. Those taking blood-thinning medication\n4. Those who are pregnant\n5. Those who could be pregnant\n6. Those who will have surgery 2 weeks before the research date\n7. Those who are scheduled to have surgery 2 weeks after the research date\n8. 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.'}, 'identificationModule': {'nctId': 'NCT03953469', 'briefTitle': 'Short-term Effects of Passiflora and Meditation on Blood Pressure and Heart Rate', 'organization': {'class': 'OTHER', 'fullName': 'University of Bridgeport'}, 'officialTitle': 'Investigating the Short-term Effects of Passiflora Incarnate and Mobile Audio-guided Meditation on Blood Pressure and Heart Rate in Naturopathic Medical Students', 'orgStudyIdInfo': {'id': '2019-02-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Placebo 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.\n\nb) will be given 1/4 tsp of blackstrap molasses placebo. Subjects may not consume caffeine or eat food during this time.\n\n(c) blood pressure readings and one heart rate will be taken 15 minutes after the baseline reading.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', '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.\n2. 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.\n3. blood pressure readings and one heart rate will be taken 15 minutes after the baseline reading.', 'interventionNames': ['Dietary Supplement: Passiflora incarnata']}], 'interventions': [{'name': 'Passiflora incarnata', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Passionflower'], 'description': 'One-time administration of 1/8 tsp solid extract Passiflora incarnata providing 900mg of Passiflora incarnata', 'armGroupLabels': ['Group II']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kimberly Sanders, ND', 'role': 'CONTACT', 'email': 'kimbersa@bridgeport.edu', 'phone': '2035764425'}, {'name': 'Mark Mattie, MD, PhD', 'role': 'CONTACT', 'email': 'mmattie@bridgeport.edu'}], 'overallOfficials': [{'name': 'Kimberly Sanders, ND', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bridgeport'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bridgeport', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Assistant Professor of Clinical Sciences', 'investigatorFullName': 'Kimberly Sanders', 'investigatorAffiliation': 'University of Bridgeport'}}}}