Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT07135193
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-21
First Post:
2025-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Protective Effects of Cordyceps Cicadae on Visual Function and Anti-Fatigue Performance in Esports Athletes
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tear break-up time', 'timeFrame': '3 hours', 'description': 'Tear film break-up time (TBUT) on the corneal surface will be recorded in seconds using corneal topography.'}, {'measure': 'Eye fatigue questionnaire', 'timeFrame': '3 hours', 'description': 'The Ocular Surface Disease Index (OSDI) was used to assess visual fatigue. The subjects were asked to fill in the questionnaire before and after taking the medicine, and the scores were calculated. Symptoms include eyestrain, discomfort, burning, irritation, pain, soreness, eye pain, double vision, photophobia, blurriness, itching, tearing, dryness, and foreign body sensation'}, {'measure': 'Accommodative Facility', 'timeFrame': '3 hours', 'description': 'Use +/- 0.50D flip mirror and special optometry cards to test the number of optometry cards that the patient can read within one minute and record the number of flip cycles.'}, {'measure': 'Visual acuity measurement', 'timeFrame': '3 hours', 'description': 'Examinations include (a) distance visual acuity (DVA) and (b) near visual acuity (NVA), recorded using the Snellen chart.'}, {'measure': 'Intraocular Pressure', 'timeFrame': '3 hours', 'description': 'The intraocular pressure (IOP) of the subjects was measured by non-contact intraocular pressure measurement in mmHg.'}, {'measure': 'Tear meniscus height (TMH)', 'timeFrame': '3 hours', 'description': 'Tear meniscus height (TMH) will be evaluated using slit-lamp biomicroscopy and recorded in millimeters.'}, {'measure': 'Meibomian gland observation', 'timeFrame': '3 hours', 'description': 'The meibomian glands will be evaluated using corneal topography to document their morphology, quantity, and size.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Visual Acuity', 'Accommodation', 'Dry Eye']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate, through a clinical human consumption trial, the effects of taking two capsules (each containing 250 mg of Cordyceps cicadae mycelium, for a total intake of 500 mg per dose) of Grape King Cordyceps cicadae mycelium on visual function and anti-fatigue performance in esports athletes.', 'detailedDescription': 'This study aims to enroll 12 participants (aged 20-30 years), who are esports players, through oral announcements for recruitment. The anticipated source of participants will be students from the Department of Multimedia Game Development and Applications, Hungkuang University of Science and Technology, second-year and above.\n\nOn the day prior to the trial, participants will undergo a baseline ophthalmic examination (serving as the control values). Following the baseline assessment, participants will undergo ophthalmic examinations after 1 hour and 2 hours of esports training, respectively, resulting in a total of three measurements. All data will be recorded in the case report form (CRF).\n\nOn the day of the trial, participants will first undergo an ophthalmic examination. After completion, all 12 participants will be randomly allocated into groups using the QuickCalcs randomization tool (GraphPad Software, https://www.graphpad.com/quickcalcs/randomize1/). Based on the random allocation, capsule packages labeled with codes 001 to 012 will be prepared, containing either the investigational product or placebo. Each package will be distributed to the corresponding participant. Of the 12 participants, 3 will be assigned to the placebo group, and 9 will be assigned to the Cordyceps cicadae mycelium group.\n\nParticipants will undergo ophthalmic examinations at 1 hour and 2 hours post-administration, and the results will be recorded in the CRF.\n\nThe investigational product will be in capsule form, containing Cordyceps cicadae mycelium (250 mg per capsule) and excipients, with no other additives. The placebo will have the same excipients and capsule composition, except without the mycelium. Each participant will take a single oral dose on the test day (2 capsules). All investigational products and placebos will be provided by Grape King Bio Ltd.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with myopia less than 700 degrees\n* Willing to participate in this study and sign the consent form\n\nExclusion Criteria:\n\n* (1) Those who have recently consumed related eye care products\n* (2) Those who have had eye infections or surgery in the past three months\n* (3) Those who have been diagnosed with eye diseases by an ophthalmologist (such as glaucoma, cataracts, macular degeneration, diabetic retinopathy, etc., or have undergone eye surgery such as cataract surgery, retinal laser surgery, myopia laser surgery, etc., which will be excluded before accepting the case)\n* (4) Those who are allergic to cicada fungus'}, 'identificationModule': {'nctId': 'NCT07135193', 'briefTitle': 'Evaluation of the Protective Effects of Cordyceps Cicadae on Visual Function and Anti-Fatigue Performance in Esports Athletes', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Evaluation of the Protective Effects of Cordyceps Cicadae on Visual Function and Anti-Fatigue Performance in Esports Athletes: A Prospective Trial', 'orgStudyIdInfo': {'id': 'CS1-25024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm', 'description': 'Cordyceps cicadae 500mg', 'interventionNames': ['Dietary Supplement: Cordyceps cicadae']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator Arm', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Blank control']}], 'interventions': [{'name': 'Cordyceps cicadae', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Cordyceps cicadae 500mg', 'armGroupLabels': ['Experimental Arm']}, {'name': 'Blank control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Blank control', 'armGroupLabels': ['Placebo Comparator Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University Hui-Wen Lin lab', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Hui-Wen Lin, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shang medical university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This experiment involves patents and intellectual property rights'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D', 'investigatorFullName': 'Hui Wen Lin', 'investigatorAffiliation': 'China Medical University Hospital'}}}}