NCT04063735

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

August 15, 2019

Last Update Submit

August 19, 2019

Conditions

Dry EyeSupplement

Keywords

Dry EyeCordyceps cicadae mycelia

Outcome Measures

Primary Outcomes (3)

  • tear film breakup time

    Tear film breakup time was used for tear quality assessments.

    day 1 to day 90.

  • 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.

  • Intra-ocular pressure

    Intra-ocular pressure was taken to assess eye pressure.

    day 1 to day 90.

Study Arms (2)

Experimental group

EXPERIMENTAL

supplement was given for 3 months.

Dietary Supplement: Cordyceps Cicadae Mycelia

Placebo group

PLACEBO COMPARATOR

Placebo was given for 3 months.

Dietary Supplement: Placebo

Interventions

Cordyceps Cicadae MyceliaDIETARY_SUPPLEMENT

Cordyceps Cicadae Mycelia supplement for 3 months

Experimental group
PlaceboDIETARY_SUPPLEMENT

Placebo was given to participants.

Placebo group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged from 20 to 60 with dry eye symptoms confirmed by ophthalmologists, and without chronic diseases.

You may not qualify if:

  • Those vulnerable to damages or loss of self-conscious, or behavior capacity, or with major illness or with critical diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • David Pei-Cheng Lin, PhD

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized double-blinded placebo study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2019

First Posted

August 21, 2019

Study Start

December 1, 2016

Primary Completion

February 7, 2017

Study Completion

November 30, 2017

Last Updated

August 21, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share