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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04063735
• Other study ID #: 16-019-A2
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: August 2019
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: November 30, 2017
• Est. primary completion date: February 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Supplement

Intervention

Dietary Supplement:
• Cordyceps Cicadae Mycelia
Cordyceps Cicadae Mycelia supplement for 3 months
• Placebo
Placebo was given to participants.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
David Pei-Cheng Lin	Grape King Bio Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tear film breakup time	Tear film breakup time was used for tear quality assessments.	day 1 to day 90.
Primary	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.
Primary	Intra-ocular pressure	Intra-ocular pressure was taken to assess eye pressure.	day 1 to day 90.