HealthyNCT04448535
Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue
A study testing Gingko Biloba in people with Healthy, run by State University of New York College of Optometry at 1 site in United States.
Trial summary
The purpose of this study is to understand the effect of Ginkgo Biloba oral supplements on retinal and choroidal ocular tissue. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Gingko Biloba
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 3 Aug 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 20 - 55 years, inclusive
- Good general and ocular health
- Corrected visual acuity of 20/40 or better
- No gingko biloba supplementation within the last 3 months
Who cannot join
- All significant ocular and any systemic disorders considered likely to affect the systemic or ocular vasculature
- History of ocular surgery, including refractive surgery
- Use of ocular medications
- Conditions where ginkgo supplementation is contraindicated
- Any eye or systemic disease that affect vision or refractive error
- Current smokers
- Subjects who are pregnant, breastfeeding, or planning conception
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to understand the effect of Ginkgo Biloba oral supplements on retinal and choroidal ocular tissue.
Read the detailed description
The study objectives are to:
- assess the changes from pre- to post- oral supplementation on retinal and choroidal thickness and blood flow, retinal oxygen saturation, ocular perfusion pressure, and retinal function
- Conditions
- Healthy
- Being tested
- Gingko Biloba
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingko BilobaDietary supplement
oral intake of Gingko Biloba, 240mg/day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Gingko Biloba | Experimental | oral intake of gingko biloba for 4 weeks Receives: Dietary Supplement: Gingko Biloba |
What is being measured
The primary outcome is the main question the study is designed to answer.
ocular blood flow
ocular blood flow measured with doppler ultrasound
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start1 Jan 2021
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York College of Optometry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Benavente, State University of New York College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448535
- Sponsor's protocol ID
- 1619383-1
- Status last verified
- Oct 2022
- First submitted
- 24 Jun 2020
- Last updated
- 24 Oct 2022
- Results posted
- No
- 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 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue
- ClinicalTrials.gov ID
- NCT04448535
- Acronym / sponsor ID
- 1619383-1
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- State University of New York College of OptometryUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 26 Jun 2020 (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.
The purpose of this study is to understand the effect of Ginkgo Biloba oral supplements on retinal and choroidal ocular tissue.
Detailed description
The study objectives are to:
- assess the changes from pre- to post- oral supplementation on retinal and choroidal thickness and blood flow, retinal oxygen saturation, ocular perfusion pressure, and retinal function
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gingko Biloba | Experimental | Dietary Supplement: Gingko Bilobaoral intake of gingko biloba for 4 weeks |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged between 20 - 55 years, inclusive
- Good general and ocular health
- Corrected visual acuity of 20/40 or better
- No gingko biloba supplementation within the last 3 months
Key exclusion criteria (7 listed)
- All significant ocular and any systemic disorders considered likely to affect the systemic or ocular vasculature
- History of ocular surgery, including refractive surgery
- Use of ocular medications
- Conditions where ginkgo supplementation is contraindicated
- Any eye or systemic disease that affect vision or refractive error
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 |
|---|---|---|
| Gingko Bilobaoral intake of Gingko Biloba, 240mg/day for 4 weeks | Dietary supplement | Gingko Biloba |
Primary outcome
ocular blood flow
Time frame: 4 weeks
ocular blood flow measured with doppler ultrasound
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 24 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingko Biloba in people with Healthy, run by State University of New York College of Optometry at 1 site in United States.
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 4 inclusion and 7 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 24 Oct 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 United States. 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?
ocular blood flow (time frame: 4 weeks). 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 24 Oct 2022.