- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07135193
- Original Trial
Evaluation of the Protective Effects of Cordyceps Cicadae on Visual Function and Anti-Fatigue Performance in Esports Athletes
Evaluation of the Protective Effects of Cordyceps Cicadae on Visual Function and Anti-Fatigue Performance in Esports Athletes: A Prospective Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
On 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).
On 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.
Participants will undergo ophthalmic examinations at 1 hour and 2 hours post-administration, and the results will be recorded in the CRF.
The 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Taichung, Taiwan
- Chung Shan Medical University Hui-Wen Lin lab
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- People with myopia less than 700 degrees
- Willing to participate in this study and sign the consent form
Exclusion Criteria:
- (1) Those who have recently consumed related eye care products
- (2) Those who have had eye infections or surgery in the past three months
- (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)
- (4) Those who are allergic to cicada fungus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo Comparator Arm
Placebo
|
Blank control
|
|
Experimental: Experimental Arm
Cordyceps cicadae 500mg
|
Cordyceps cicadae 500mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tear break-up time
Time Frame: 3 hours
|
Tear film break-up time (TBUT) on the corneal surface will be recorded in seconds using corneal topography.
|
3 hours
|
|
Eye fatigue questionnaire
Time Frame: 3 hours
|
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
|
3 hours
|
|
Accommodative Facility
Time Frame: 3 hours
|
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.
|
3 hours
|
|
Visual acuity measurement
Time Frame: 3 hours
|
Examinations include (a) distance visual acuity (DVA) and (b) near visual acuity (NVA), recorded using the Snellen chart.
|
3 hours
|
|
Intraocular Pressure
Time Frame: 3 hours
|
The intraocular pressure (IOP) of the subjects was measured by non-contact intraocular pressure measurement in mmHg.
|
3 hours
|
|
Tear meniscus height (TMH)
Time Frame: 3 hours
|
Tear meniscus height (TMH) will be evaluated using slit-lamp biomicroscopy and recorded in millimeters.
|
3 hours
|
|
Meibomian gland observation
Time Frame: 3 hours
|
The meibomian glands will be evaluated using corneal topography to document their morphology, quantity, and size.
|
3 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hui-Wen Lin, Ph.D, Chung Shang medical university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS1-25024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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