Dry EyeNCT04063735
Alleviating Effects Against Dry Eye by Oral Intake of Cordyceps Cicadae Mycelia
A study testing Cordyceps Cicadae Mycelia in people with Dry Eye and Supplement, run by David Pei-Cheng Lin.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Dry Eye, Supplement
- What is being tested?
- Cordyceps Cicadae Mycelia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged from 20 to 60 with dry eye symptoms confirmed by ophthalmologists, and without chronic diseases.
Who cannot join
- Those vulnerable to damages or loss of self-conscious, or behavior capacity, or with major illness or with critical diseases.
About this study
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.
Read the 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.
- Conditions
- Dry Eye, Supplement
- Being tested
- Cordyceps Cicadae Mycelia, Placebo
- Keywords
- Dry Eye, Cordyceps cicadae mycelia
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cordyceps Cicadae MyceliaDietary supplement
Cordyceps Cicadae Mycelia supplement for 3 months
PlaceboDietary supplement
Placebo was given to participants.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | supplement was given for 3 months. Receives: Dietary Supplement: Cordyceps Cicadae Mycelia |
| Placebo group | Placebo comparator | Placebo was given for 3 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
tear film breakup time
Tear film breakup time was used for tear quality assessments.
Measured: 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.
Measured: day 1 to day 90.
Intra-ocular pressure
Intra-ocular pressure was taken to assess eye pressure.
Measured: day 1 to day 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start1 Dec 2016
- Primary completion7 Feb 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blinded placebo study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Pei-Cheng Lin
- Sponsor type
- University, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Responsible party
- Sponsor-investigator, David Pei-Cheng Lin, Chung Shan Medical University
- Investigators
- David Pei-Cheng Lin, PhD, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063735
- Sponsor's protocol ID
- 16-019-A2
- Status last verified
- Aug 2019
- First submitted
- 15 Aug 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviating Effects Against Dry Eye by Oral Intake of Cordyceps Cicadae Mycelia
- ClinicalTrials.gov ID
- NCT04063735
- Acronym / sponsor ID
- 16-019-A2
- Conditions
- Dry Eye, Supplement
- Keywords
- Dry Eye, Cordyceps cicadae mycelia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- David Pei-Cheng LinUniversity, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blinded placebo study
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: Cordyceps Cicadae Myceliasupplement was given for 3 months. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo was given for 3 months. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults aged from 20 to 60 with dry eye symptoms confirmed by ophthalmologists, and without chronic diseases.
Key exclusion criteria (1 listed)
- Those vulnerable to damages or loss of self-conscious, or behavior capacity, or with major illness or with critical diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cordyceps Cicadae MyceliaCordyceps Cicadae Mycelia supplement for 3 months | Dietary supplement | Experimental group |
| PlaceboPlacebo was given to participants. | Dietary supplement | Placebo group |
Primary outcome
tear film breakup time
Time frame: day 1 to day 90.
Tear film breakup time was used for tear quality assessments.
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.
Intra-ocular pressure
Time frame: day 1 to day 90.
Intra-ocular pressure was taken to assess eye pressure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Pei-Cheng Lin, PhD principal investigator
Chung Shan Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Cordyceps Cicadae Mycelia in people with Dry Eye and Supplement, run by David Pei-Cheng Lin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tear film breakup time (time frame: day 1 to day 90.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.