Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT04448535
Status:
COMPLETED
Last Update Posted:
2022-10-24
First Post:
2020-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000096983', 'term': 'Ginkgo Extract'}], 'ancestors': [{'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-20', 'studyFirstSubmitDate': '2020-06-24', 'studyFirstSubmitQcDate': '2020-06-24', 'lastUpdatePostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ocular blood flow', 'timeFrame': '4 weeks', 'description': 'ocular blood flow measured with doppler ultrasound'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand the effect of Ginkgo Biloba oral supplements on retinal and choroidal ocular tissue.', 'detailedDescription': 'The study objectives are to:\n\n1\\. assess the changes from pre- to post- oral supplementation on retinal and choroidal thickness and blood flow, retinal oxygen saturation, ocular perfusion pressure, and retinal function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 20 - 55 years, inclusive\n* Good general and ocular health\n* Corrected visual acuity of 20/40 or better\n* No gingko biloba supplementation within the last 3 months\n\nExclusion Criteria:\n\n* All significant ocular and any systemic disorders considered likely to affect the systemic or ocular vasculature\n* History of ocular surgery, including refractive surgery\n* Use of ocular medications\n* Conditions where ginkgo supplementation is contraindicated\n* Any eye or systemic disease that affect vision or refractive error\n* Current smokers\n* Subjects who are pregnant, breastfeeding, or planning conception'}, 'identificationModule': {'nctId': 'NCT04448535', 'briefTitle': 'Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York College of Optometry'}, 'officialTitle': 'Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue', 'orgStudyIdInfo': {'id': '1619383-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gingko Biloba', 'description': 'oral intake of gingko biloba for 4 weeks', 'interventionNames': ['Dietary Supplement: Gingko Biloba']}], 'interventions': [{'name': 'Gingko Biloba', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oral intake of Gingko Biloba, 240mg/day for 4 weeks', 'armGroupLabels': ['Gingko Biloba']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY College of Optometry', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York College of Optometry', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Clinical Professor', 'investigatorFullName': 'Alexandra Benavente', 'investigatorAffiliation': 'State University of New York College of Optometry'}}}}