Back to resultsAlleviating Effects Against Dry Eye by Oral Intake of Cordyceps Cicadae Mycelia
Primary Purpose
Dry Eye, Supplement
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cordyceps Cicadae Mycelia
Placebo
Sponsored by
About this trial
This is an interventional other trial for Dry Eye focused on measuring Dry Eye, Cordyceps cicadae mycelia
Eligibility Criteria
Inclusion Criteria:
- Adults aged from 20 to 60 with dry eye symptoms confirmed by ophthalmologists, and without chronic diseases.
Exclusion Criteria:
- Those vulnerable to damages or loss of self-conscious, or behavior capacity, or with major illness or with critical diseases.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Placebo group
Arm Description
supplement was given for 3 months.
Placebo was given for 3 months.
Outcomes
Primary Outcome Measures
tear film breakup time
Tear film breakup time was used for tear quality assessments.
Cornea surface scores based on Efron grading system
Cornea surface scores based on Efron grading system was used for assessment of cornea surface damages.
Intra-ocular pressure
Intra-ocular pressure was taken to assess eye pressure.
Secondary Outcome Measures
Full Information
NCT ID
NCT04063735
First Posted
August 15, 2019
Last Updated
August 19, 2019
Sponsor
David Pei-Cheng Lin
Collaborators
Grape King Bio Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04063735
Brief Title
Alleviating Effects Against Dry Eye by Oral Intake of Cordyceps Cicadae Mycelia
Official Title
Alleviating Effects Against Dry Eye by Oral Intake of Cordyceps Cicadae Mycelia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
February 7, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Pei-Cheng Lin
Collaborators
Grape King Bio Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Supplement
Keywords
Dry Eye, Cordyceps cicadae mycelia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized double-blinded placebo study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
supplement was given for 3 months.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo was given for 3 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cordyceps Cicadae Mycelia
Intervention Description
Cordyceps Cicadae Mycelia supplement for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo was given to participants.
Primary Outcome Measure Information:
Title
tear film breakup time
Description
Tear film breakup time was used for tear quality assessments.
Time Frame
day 1 to day 90.
Title
Cornea surface scores based on Efron grading system
Description
Cornea surface scores based on Efron grading system was used for assessment of cornea surface damages.
Time Frame
day 1 to day 90.
Title
Intra-ocular pressure
Description
Intra-ocular pressure was taken to assess eye pressure.
Time Frame
day 1 to day 90.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults aged from 20 to 60 with dry eye symptoms confirmed by ophthalmologists, and without chronic diseases.
Exclusion Criteria:
Those vulnerable to damages or loss of self-conscious, or behavior capacity, or with major illness or with critical diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Pei-Cheng Lin, PhD
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Alleviating Effects Against Dry Eye by Oral Intake of Cordyceps Cicadae Mycelia
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