Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 3:51 PM
Study NCT ID:
NCT04063735
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2019-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alleviating Effects Against Dry Eye by Oral Intake of Cordyceps Cicadae Mycelia
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', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized double-blinded placebo study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2019-08-15', 'studyFirstSubmitQcDate': '2019-08-19', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tear film breakup time', 'timeFrame': 'day 1 to day 90.', 'description': 'Tear film breakup time was used for tear quality assessments.'}, {'measure': 'Cornea surface scores based on Efron grading system', 'timeFrame': 'day 1 to day 90.', 'description': 'Cornea surface scores based on Efron grading system was used for assessment of cornea surface damages.'}, {'measure': 'Intra-ocular pressure', 'timeFrame': 'day 1 to day 90.', 'description': 'Intra-ocular pressure was taken to assess eye pressure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry Eye', 'Cordyceps cicadae mycelia'], 'conditions': ['Dry Eye', 'Supplement']}, 'descriptionModule': {'briefSummary': 'Cordyceps cicadae mycelia was tested for amelioration of dry eye symptoms through dietary supplementation. Its efficacy in relief of human dry eye status was assessed by randomized, double-blinded tests, including multiple assessments. The results were compared between the placebo group and the experimental group.', 'detailedDescription': 'Former animal studies had shown that Cordyceps cicadae mycelia can effectively ameliorate UVB-induced dry eye symptoms. This study further investigated its efficacy in human dry eye status by randomized, double-blinded tests, including dry eye questionnaires, blood tests, salivary tests, tear volume test, intra-ocular pressure assessments, ocular surface photography, corneal fluorescein stain, tear film breakup time test, fundus photography, and cornea impression cytology. All tests were performed again after 3 months of dietary supplement of either samples or placebo. A total of 97 participants completed the trial. The data were analyzed by paired-t test and compared between the placebo and the experimental groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged from 20 to 60 with dry eye symptoms confirmed by ophthalmologists, and without chronic diseases.\n\nExclusion Criteria:\n\n* Those vulnerable to damages or loss of self-conscious, or behavior capacity, or with major illness or with critical diseases.'}, 'identificationModule': {'nctId': 'NCT04063735', 'briefTitle': 'Alleviating Effects Against Dry Eye by Oral Intake of Cordyceps Cicadae Mycelia', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Alleviating Effects Against Dry Eye by Oral Intake of Cordyceps Cicadae Mycelia', 'orgStudyIdInfo': {'id': '16-019-A2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'supplement was given for 3 months.', 'interventionNames': ['Dietary Supplement: Cordyceps Cicadae Mycelia']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo was given for 3 months.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Cordyceps Cicadae Mycelia', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Cordyceps Cicadae Mycelia supplement for 3 months', 'armGroupLabels': ['Experimental group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo was given to participants.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David Pei-Cheng Lin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Pei-Cheng Lin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grape King Bio Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'David Pei-Cheng Lin', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}