Alleviating Effects Against Dry Eye by Oral Intake of Cordyceps Cicadae Mycelia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Alleviating Effects Against Dry Eye by Oral Intake of Cordyceps Cicadae Mycelia

Conditions
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Dry Eye, Supplement

Intervention / Treatment
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* Dietary Supplement: Cordyceps Cicadae Mycelia
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized double-blinded placebo study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>supplement was given for 3 months. | Dietary Supplement: Cordyceps Cicadae Mycelia<br>* Cordyceps Cicadae Mycelia supplement for 3 months<br>|
| Placebo Comparator: Placebo group<br>Placebo was given for 3 months. | Dietary Supplement: Placebo<br>* Placebo was given to participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tear film breakup time | Tear film breakup time was used for tear quality assessments. | day 1 to day 90. | 
| Cornea surface scores based on Efron grading system | Cornea surface scores based on Efron grading system was used for assessment of cornea surface damages. | day 1 to day 90. | 
| Intra-ocular pressure | Intra-ocular pressure was taken to assess eye pressure. | day 1 to day 90. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye, Cordyceps cicadae mycelia