SupplementNCT05304299
Alleviating Effects Against High Intraocular Pressure by Oral Intake of Cordyceps Cicadae Mycelia
A study testing Cordyceps Cicadae Mycelia in people with Supplement, run by Han-Hsin Chang at 1 site in Taiwan.
Trial summary
This study will investigate the effects of lowering intraocular pressure by oral intake of Cordyceps cicadae mycelia, to provide evidence-based data for high intraocular pressure relief. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Supplement
- What is being tested?
- Cordyceps Cicadae Mycelia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Mar 2020to 31 Dec 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 75 years old, regardless of gender.
- Pre-test confirmation of high intraocular pressure.
- Subjects should understand the trial and agree to join the project.
Who cannot join
- Age under 20 or over 75 years.
- Use intraocular pressure lowering drugs other than Taflotan (saflutan).
- Using beta-blockers or diuretics.
- Being pregnant.
- Disabled individuals with specific diseases or malfunction, for example tumours at terminal stage, blindness.
- Loss of self-consciousness and behavioral capacity.
- Patients with major diseases.
- Withdrawal criteria All subjects may withdraw at any time without any reason. The act of withdraw does not affect rights for them to seek medical advice or treatments.
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the effects of lowering intraocular pressure by oral intake of Cordyceps cicadae mycelia, to provide evidence-based data for high intraocular pressure relief.
Read the detailed description
Study purpose This study investigated the effeicacy of oral Cordyceps cicadae mycelia for the relief of high intraocular pressure.
Subjects
- The total recruitment of subjects is 60 people, aged between 20 to 75 years.
- Subjects with intraocular pressure more than or equal to 21 mmHg are included, irrespective of whether on us of Taflotan (saflutan).
Methods
- Informed consents will be obtained from subjects first. The subjects with pre-test intraocular pressure over or equal 21 mm Hg are advised to orally take two capsules containing a total of 500 mg of Cordyceps cicadae mycelia. After 90 minutes, the subjects are evaluated for intraocular pressure.
The pre-test and and post-intake intraocualr pressure and blood pressure data will be compared by paired t test for significant differences if any.
- Conditions
- Supplement
- Being tested
- Cordyceps Cicadae Mycelia
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 will be given to test its potential for alleviation of high intraocular pressure.
| Study group | Role | What they receive |
|---|---|---|
| Cordyceps Cicadae Mycelia only | Experimental | Only Cordyceps Cicadae Mycelia will be given. Receives: Dietary Supplement: Cordyceps Cicadae Mycelia |
| Cordyceps Cicadae Mycelia with Taflotan (saflutan) | Experimental | Cordyceps Cicadae Mycelia with Taflotan (saflutan) will be given. Receives: Dietary Supplement: Cordyceps Cicadae Mycelia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Intraocular pressure of both eyes will be assessed
Measured: 0 minutes (before given Cordyceps Cicadae Mycelia)
Intraocular pressure
Intraocular pressure of both eyes will be assessed
Measured: 90 minutes after given Cordyceps Cicadae Mycelia
Blood pressure
Both systolic and diastolic blood pressures will be assessed
Measured: 0 minutes (before given Cordyceps Cicadae Mycelia)
Blood pressure
Both systolic and diastolic blood pressures will be assessed
Measured: 90 minutes after given Cordyceps Cicadae Mycelia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start10 Mar 2020
- Primary completion31 Jul 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SupplementStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of subjects are subject to pre-test and post-test intraocular pressure measurements.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Han-Hsin Chang
- Sponsor type
- University, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Responsible party
- Sponsor-investigator, Han-Hsin Chang, Chung Shan Medical University
- Investigators
- Han-Hsin Chang, PhD, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304299
- Sponsor's protocol ID
- IRB-19-024
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2022
- Last updated
- 31 Mar 2022
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviating Effects Against High Intraocular Pressure by Oral Intake of Cordyceps Cicadae Mycelia
- ClinicalTrials.gov ID
- NCT05304299
- Acronym / sponsor ID
- IRB-19-024
- Conditions
- Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Han-Hsin ChangUniversity, hospital or other
- Collaborators
- Grape King Bio Ltd.
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 31 Mar 2022 (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.
This study will investigate the effects of lowering intraocular pressure by oral intake of Cordyceps cicadae mycelia, to provide evidence-based data for high intraocular pressure relief.
Detailed description
Study purpose This study investigated the effeicacy of oral Cordyceps cicadae mycelia for the relief of high intraocular pressure.
Subjects
- The total recruitment of subjects is 60 people, aged between 20 to 75 years.
- Subjects with intraocular pressure more than or equal to 21 mmHg are included, irrespective of whether on us of Taflotan (saflutan).
Methods
- Informed consents will be obtained from subjects first. The subjects with pre-test intraocular pressure over or equal 21 mm Hg are advised to orally take two capsules containing a total of 500 mg of Cordyceps cicadae mycelia. After 90 minutes, the subjects are evaluated for intraocular pressure.
The pre-test and and post-intake intraocualr pressure and blood pressure data will be compared by paired t test for significant differences if any.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of subjects are subject to pre-test and post-test intraocular pressure measurements.
| Arm | Type | Receives |
|---|---|---|
| Cordyceps Cicadae Mycelia only | Experimental | Dietary Supplement: Cordyceps Cicadae MyceliaOnly Cordyceps Cicadae Mycelia will be given. |
| Cordyceps Cicadae Mycelia with Taflotan (saflutan) | Experimental | Dietary Supplement: Cordyceps Cicadae MyceliaCordyceps Cicadae Mycelia with Taflotan (saflutan) will be given. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20 and 75 years old, regardless of gender.
- Pre-test confirmation of high intraocular pressure.
- Subjects should understand the trial and agree to join the project.
Key exclusion criteria (8 listed)
- Age under 20 or over 75 years.
- Use intraocular pressure lowering drugs other than Taflotan (saflutan).
- Using beta-blockers or diuretics.
- Being pregnant.
- Disabled individuals with specific diseases or malfunction, for example tumours at terminal stage, blindness.
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 will be given to test its potential for alleviation of high intraocular pressure. | Dietary supplement | Cordyceps Cicadae Mycelia only, Cordyceps Cicadae Mycelia with Taflotan (saflutan) |
Primary outcome
Intraocular pressure
Time frame: 0 minutes (before given Cordyceps Cicadae Mycelia)
Intraocular pressure of both eyes will be assessed
Intraocular pressure
Time frame: 90 minutes after given Cordyceps Cicadae Mycelia
Intraocular pressure of both eyes will be assessed
Blood pressure
Time frame: 0 minutes (before given Cordyceps Cicadae Mycelia)
Both systolic and diastolic blood pressures will be assessed
Blood pressure
Time frame: 90 minutes after given Cordyceps Cicadae Mycelia
Both systolic and diastolic blood pressures will be assessed
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 31 Mar 2022.
- 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.
Han-Hsin Chang, PhD principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cordyceps Cicadae Mycelia in people with Supplement, run by Han-Hsin Chang at 1 site in Taiwan.
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 3 inclusion and 8 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Intraocular pressure (time frame: 0 minutes (before given Cordyceps Cicadae Mycelia)). The study lists 4 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 31 Mar 2022.