Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-26 @ 7:25 PM
Study NCT ID:
NCT02572102
Status:
UNKNOWN
Last Update Posted:
2015-10-08
First Post:
2015-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Energy Drinks and Panax Ginseng on Heart Rhythm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-10-27', 'releaseDate': '2021-09-29'}], 'estimatedResultsFirstSubmitDate': '2021-09-29'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D061215', 'term': 'Energy Drinks'}, {'id': 'C000713447', 'term': 'Asian ginseng'}], 'ancestors': [{'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-07', 'studyFirstSubmitDate': '2015-10-06', 'studyFirstSubmitQcDate': '2015-10-07', 'lastUpdatePostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QTc interval changes', 'timeFrame': '5.5 hours over 3 visits'}, {'measure': 'Systolic blood pressure changes', 'timeFrame': '5.5 hours over 3 visits'}], 'secondaryOutcomes': [{'measure': 'QT interval changes', 'timeFrame': '5.5 hours over 3 visits'}, {'measure': 'PR interval changes', 'timeFrame': '5.5 hours over 3 visits'}, {'measure': 'QRS duration changes', 'timeFrame': '5.5 hours over 3 visits'}, {'measure': 'Heart rate changes', 'timeFrame': '5.5 hours over 3 visits'}, {'measure': 'Diastolic blood pressure changes', 'timeFrame': '5.5 hours over 3 visits'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ECG', 'Blood Pressure', 'Energy Drinks', 'Panax Ginseng'], 'conditions': ['Electrical Alternation of Heart', 'Blood Pressure']}, 'descriptionModule': {'briefSummary': 'To assess the cardiac effects of an energy drink and Panax Ginseng in healthy volunteers.', 'detailedDescription': 'Energy drinks are composed of a variety of ingredients such as caffeine, taurine, and panax ginseng amongst others. The safety and efficacy of these ingredients individually and in combination need further exploration. This study is designed to assess the electrocardiographic and blood pressure effects of energy drinks and panax ginseng in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female adults 18-40 years old.\n\nExclusion Criteria:\n\n* Baseline corrected QT (QTc) interval greater than 440 milliseconds,\n* blood pressure at initial screening appointment greater than 140/90 mmHg,\n* concurrent use of prescriptions or OTC medications taken on a daily basis,\n* pregnant females,\n* patients with any baseline ECG abnormalities.'}, 'identificationModule': {'nctId': 'NCT02572102', 'briefTitle': 'Impact of Energy Drinks and Panax Ginseng on Heart Rhythm', 'organization': {'class': 'OTHER', 'fullName': 'University of the Pacific'}, 'officialTitle': 'Impact of Energy Drinks and Panax Ginseng on Heart Rhythm in Healthy Volunteers', 'orgStudyIdInfo': {'id': '15-119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Energy Drink', 'description': 'Two 16 ounce containers of an Energy Drink', 'interventionNames': ['Dietary Supplement: Energy Drink']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Panax Ginseng', 'description': '800 mg of Panax Ginseng in 70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water', 'interventionNames': ['Dietary Supplement: Panax Ginseng']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Energy Drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Energy Drink, two 16oz containers consumed in 45 minutes', 'armGroupLabels': ['Energy Drink']}, {'name': 'Panax Ginseng', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Panax Ginseng, lime juice, water and cherry flavoring', 'armGroupLabels': ['Panax Ginseng']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Lime juice, water and cherry flavoring', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of the Pacific', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-09-29', 'type': 'RELEASE'}, {'date': '2021-10-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of the Pacific'}}}}