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Completed

NCT Number: NCT04063735

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Supplement

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cordyceps Cicadae Mycelia

Dietary Supplement

Cordyceps Cicadae Mycelia supplement for 3 months

Placebo

Dietary Supplement

Placebo was given to participants.

Primary outcomes

  1. tear film breakup time

    Time frame: day 1 to day 90.

    Tear film breakup time was used for tear quality assessments.

  2. Cornea surface scores based on Efron grading system

    Time frame: day 1 to day 90.

    Cornea surface scores based on Efron grading system was used for assessment of cornea surface damages.

  3. Intra-ocular pressure

    Time frame: day 1 to day 90.

    Intra-ocular pressure was taken to assess eye pressure.

Sponsors and collaborators

Lead sponsor

David Pei-Cheng Lin

Other

Collaborators

  • Grape King Bio Ltd.

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 21, 2019
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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