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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04063735
Other study ID # 16-019-A2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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.
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