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

NCT ID: NCT04063735

Last Updated: 2019-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2017-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Dry Eye Supplement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized double-blinded placebo study
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental group

supplement was given for 3 months.

Group Type EXPERIMENTAL

Cordyceps Cicadae Mycelia

Intervention Type DIETARY_SUPPLEMENT

Cordyceps Cicadae Mycelia supplement for 3 months

Placebo group

Placebo was given for 3 months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo was given to participants.

Interventions

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Cordyceps Cicadae Mycelia

Cordyceps Cicadae Mycelia supplement for 3 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo was given to participants.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grape King Bio Ltd.

INDUSTRY

Sponsor Role collaborator

David Pei-Cheng Lin

OTHER

Sponsor Role lead

Responsible Party

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David Pei-Cheng Lin

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David Pei-Cheng Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Other Identifiers

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16-019-A2

Identifier Type: -

Identifier Source: org_study_id

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