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

August 19, 2019 updated by: David Pei-Cheng Lin
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
supplement was given for 3 months.
Dietary supplement: Cordyceps Cicadae Mycelia
Cordyceps Cicadae Mycelia supplement for 3 months
Placebo Comparator: Placebo group
Placebo was given for 3 months.
Dietary supplement: Placebo
Placebo was given to participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tear film breakup time
Time Frame: day 1 to day 90.
Tear film breakup time was used for tear quality assessments.
day 1 to day 90.
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.
day 1 to day 90.
Intra-ocular pressure
Time Frame: day 1 to day 90.
Intra-ocular pressure was taken to assess eye pressure.
day 1 to day 90.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Pei-Cheng Lin

Collaborators

Grape King Bio Ltd.

Investigators

  • Principal Investigator: David Pei-Cheng Lin, PhD, Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

February 7, 2017

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

August 15, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (Actual)

August 21, 2019

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-019-A2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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