Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-04 @ 9:58 PM
Study NCT ID:
NCT02019368
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2013-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antioxidant Effect of Aged Garlic Extract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-17', 'studyFirstSubmitDate': '2013-12-18', 'studyFirstSubmitQcDate': '2013-12-18', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary 8-hydroxydeoxyguanosine (8-OHdG)', 'timeFrame': 'Every 4 weeks (Overall 12 weeks)'}], 'secondaryOutcomes': [{'measure': 'High sensitive CRP', 'timeFrame': 'Every 4 weeks (Overall 12 weeks)'}, {'measure': 'Blood pressure', 'timeFrame': 'Every 4 weeks (Overall 12 weeks)'}, {'measure': 'Indices of the second derivative of photoplethysmogram (SDPTG)', 'timeFrame': 'Every 4 weeks (Overall 12 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heavy Smoker or Non-smoker']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo controlled, crossover study to determine the antioxidant effect of aged garlic extract. This study will also compare the oxidative status in heavy smokers with that in non-smokers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smoking (at least 20 cigarettes per day) or non-smoking (more than 20 years)\n\nExclusion Criteria:\n\n* Under medication for chronic disease\n* Garlic allergy\n* Engaging in vigorous exercise\n* Taking drugs or functional food that may possess antioxidant property\n* Participation in any clinical trial within 90 days of the commencement of the trial\n* Renal or hepatic dysfunction\n* Heart disease'}, 'identificationModule': {'nctId': 'NCT02019368', 'briefTitle': 'Antioxidant Effect of Aged Garlic Extract', 'organization': {'class': 'OTHER', 'fullName': 'Hiroshima University'}, 'officialTitle': 'A Randomized, Double-blind, Placebo Controlled, Crossover Study to Evaluate the Antioxidant Effect of Aged Garlic Extract in Heavy Smokers', 'orgStudyIdInfo': {'id': 'eki-843'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Smoker subjects take 6 capsules once a day for 4 weeks.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Aged garlic extract', 'description': 'Smoker subjects take 1.5 g of aged garlic extract in 6 capsules once a day for 4 weeks.', 'interventionNames': ['Dietary Supplement: Aged garlic extract']}, {'type': 'NO_INTERVENTION', 'label': 'Non-smoker', 'description': 'Oxidative status in non-smoker'}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}, {'name': 'Aged garlic extract', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Aged garlic extract']}]}, 'contactsLocationsModule': {'locations': [{'zip': '734-8551', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima University', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}], 'overallOfficials': [{'name': 'Fumiko Higashikawa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hiroshima University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hiroshima University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wakunaga Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Fumiko Higashikawa', 'investigatorAffiliation': 'Hiroshima University'}}}}