Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-29 @ 4:52 AM
Study NCT ID:
NCT02802150
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2016-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Oral Zanthoxylum Schinifolium Seed Oil in Individuals With Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-13', 'studyFirstSubmitDate': '2016-02-17', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'change from fatty acid composition of erythrocyte membrane', 'timeFrame': 'baseline, 10 weeks', 'description': 'Fatty acid composition(%)\n\n* Palmitic (C16:0)\n* Palmitoleic (C16:1)\n* Stearic (C18:0)\n* Oleic (C18:1)\n* iso-Oleic (C18:1cis)\n* Linoleic (C18:2)\n* Linolenic (C18:3) --\\> Measures to assess differences baseline and after the 10-week intervention period.'}], 'primaryOutcomes': [{'measure': 'change from Schirmer test(mm)', 'timeFrame': 'baseline, 5weeks, 10 weeks', 'description': 'Measures to assess differences baseline and after the 5-week and 10-week intervention period'}, {'measure': 'change from tear break-up time(seconds)', 'timeFrame': 'baseline, 5weeks, 10 weeks', 'description': 'Measures to assess differences baseline and after the 5-week and 10-week'}, {'measure': 'change from corneal staining(0 to 5 grade)', 'timeFrame': 'baseline, 5weeks, 10 weeks', 'description': 'Measures to assess differences baseline and after the 5-week and 10-week'}, {'measure': 'change from ocular surface disease index(0 to 100 score)', 'timeFrame': 'baseline, 5weeks, 10 weeks', 'description': 'Measures to assess differences baseline and after the 5-weeks and 10-weeks'}], 'secondaryOutcomes': [{'measure': 'change from interleukin-13(pg/mL)', 'timeFrame': 'baseline, 10 weeks', 'description': 'Measures to assess differences baseline and after the 10-weeks'}, {'measure': 'change from interferon-gamma(pg/mL)', 'timeFrame': 'baseline, 10 weeks', 'description': 'Measures to assess differences baseline and after the 10-weeks'}, {'measure': 'change from interleukin-1β(pg/mL)', 'timeFrame': 'baseline, 10 weeks', 'description': 'Measures to assess differences baseline and after the 10-weeks'}, {'measure': 'change from interleukin-17(pg/mL)', 'timeFrame': 'baseline, 10 weeks', 'description': 'Measures to assess differences baseline and after the 10-weeks'}, {'measure': 'change from malondialdehyde(nU/L)', 'timeFrame': 'baseline, 10 weeks', 'description': 'Measures to assess differences baseline and after the 10-weeks'}, {'measure': 'change from low-density lipoprotein(pmol/mg)', 'timeFrame': 'baseline, 10 weeks', 'description': 'Measures to assess differences baseline and after the 10-weeks'}, {'measure': 'change from total cholesterol(mg/dL)', 'timeFrame': 'baseline, 10 weeks', 'description': 'Measures to assess differences baseline and after the 10-weeks'}, {'measure': 'change from triglyceride(mg/dL)', 'timeFrame': 'baseline, 10 weeks', 'description': 'Measures to assess differences baseline and after the 10-weeks'}, {'measure': 'change from high-density lipoprotein cholesterol(mg/dL)', 'timeFrame': 'baseline, 10 weeks', 'description': 'Measures to assess differences baseline and after the 10-weeks'}, {'measure': 'change from low-density lipoprotein cholesterol(mg/dL)', 'timeFrame': 'baseline, 10 weeks', 'description': 'Measures to assess differences baseline and after the 10-weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Zanthoxylum schinifolium seed Oil', 'soy bean oil', 'omega-3 fatty acid', 'dry eye disease'], 'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical efficacy and safety of 10-weeks oral consumption of Zanthoxylum schinifolium seed Oil (ZSO) in patients with mild dry eye disease.', 'detailedDescription': 'In this double-blind, randomized and placebo-controlled trial, twenty participants experiencing dry eyes symptoms were recruited, and randomly assigned to consume 4 g/day of either ZSO or soy bean oil (SBO) as placebo for 10 weeks. All participants completed the study. Follow-ups of dry eye symptoms and objective signs, inflammatory and oxidative stress markers, and blood lipid analysis were performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* men and women\n* 20 to 70 years with dry eye disease\n* low tear break-up time (TBUT) (\\<10 seconds) or low Schirmer score (with application of local anesthetic) (\\<10mm for 5 min) or presence of corneal and conjunctival damage at the time of screening.\n* blood level of triglyceride higher than 150 mg/dL or HDL-cholesterol less than 40 and 50 mg/dL for men and women, respectively.\n\nExclusion Criteria:\n\n* under the anti-inflammatory eye drops for dry eye (topical steroid and topical cyclosporin)\n* hypolipidemic medication within 3 months of study entry\n* history of chronic disease\n* any clinical trial using an investigative medicinal product within 2 months before the first dose of the present study\n* allergic or hypersensitive to any of the ingredients in the test products.\n* women who were pregnant or breast feeding\n* a history of alcoholism or drug abuse or medical or psychological conditions'}, 'identificationModule': {'nctId': 'NCT02802150', 'briefTitle': 'The Effect of Oral Zanthoxylum Schinifolium Seed Oil in Individuals With Dry Eye Disease', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'orgStudyIdInfo': {'id': 'CTCF2_2014_SC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Zanthoxylum schinifolium seed Oil', 'description': 'Zanthoxylum schinifolium seed Oil 100% (4g/day)', 'interventionNames': ['Dietary Supplement: Zanthoxylum Schinifolium Seed Oil(4g/day)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'soy bean oil', 'description': 'soy bean oil 99.9%, edible dyes 0.01% (4g/day)', 'interventionNames': ['Dietary Supplement: Soy Bean Oil;placebo(4g/day)']}], 'interventions': [{'name': 'Zanthoxylum Schinifolium Seed Oil(4g/day)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'parallel design', 'armGroupLabels': ['Zanthoxylum schinifolium seed Oil']}, {'name': 'Soy Bean Oil;placebo(4g/day)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'parallel design', 'armGroupLabels': ['soy bean oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560-822', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Clinical Trial Center for Functional Foods; Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'zip': '560-822', 'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Clinical Trial Center for Functional Foods', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D.', 'investigatorFullName': 'Soo-Wan Chae', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}