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

Not Applicable

Completed

• Conditions: Supplement; Dry Eye
• Interventions: Dietary Supplement: Cordyceps Cicadae Mycelia; Dietary Supplement: Placebo

• Registration Number: NCT04063735
• Lead Sponsor: David Pei-Cheng Lin

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.

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2017-02-07
• Study Completion: 2017-11-30
• Status Verified: 2019-08
• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-19
• Last Update Submitted: 2019-08-19
• Study First Posted: 2019-08-21
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Cordyceps Cicadae Mycelia	supplement was given for 3 months.
Placebo group	Placebo	Placebo was given for 3 months.

Primary Outcome Measures

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