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:
China Medical University Hospital
Organization:
Study Overview
Official Title:
Evaluation of the Protective Effects of Cordyceps Cicadae on Visual Function and Anti-Fatigue Performance in Esports Athletes: A Prospective Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: