- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04448535
Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue
October 20, 2022 updated by: Alexandra Benavente, State University of New York College of Optometry
The purpose of this study is to understand the effect of Ginkgo Biloba oral supplements on retinal and choroidal ocular tissue.
Study Overview
Detailed Description
The study objectives are to:
1. 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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10036
- SUNY College of Optometry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gingko Biloba
oral intake of gingko biloba for 4 weeks
|
oral intake of Gingko Biloba, 240mg/day for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ocular blood flow
Time Frame: 4 weeks
|
ocular blood flow measured with doppler ultrasound
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
August 3, 2022
Study Completion (Actual)
August 3, 2022
Study Registration Dates
First Submitted
June 24, 2020
First Submitted That Met QC Criteria
June 24, 2020
First Posted (Actual)
June 26, 2020
Study Record Updates
Last Update Posted (Actual)
October 24, 2022
Last Update Submitted That Met QC Criteria
October 20, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 1619383-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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