Effects of Ginkgo (Gingko Biloba) on Retinal and Choroida... | NCT04448535

Studies
Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue

NCT04448535

Sponsor

State University of New York College of Optometry

Status

Completed

Last Update Posted

Oct 24, 2022Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Gingko Biloba

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Aug 3, 2022Actual

Completion Date

Aug 3, 2022Actual

First Submitted Date

Jun 24, 2020

First Submission Date that Met QC Criteria

Jun 24, 2020

First Posted Date

Jun 26, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2022

Last Update Posted Date

Oct 24, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexandra Benavente, Associate Clinical Professor, State University of New York College of OptometryPrincipal Investigator

Lead Sponsor

State University of New York College of OptometryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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:

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gingko Biloba	Experimental	oral intake of gingko biloba for 4 weeks	Dietary Supplement: Gingko Biloba

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gingko Biloba	Dietary Supplement	oral intake of Gingko Biloba, 240mg/day for 4 weeks	Gingko Biloba

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ocular blood flow	ocular blood flow measured with doppler ultrasound	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SUNY College of Optometry		New York	New York	10036	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000096983	Ginkgo Extract

Ancestor Terms

ID	Term
D010936	Plant Extracts
D028321	Plant Preparations
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided