UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016618
Receipt number R000019230
Scientific Title Effect on working memory and brain blood flow by ingestion of ginkgo biloba in healthy volunteers
Date of disclosure of the study information 2015/02/25
Last modified on 2018/08/28 11:36:51

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Basic information

Public title

Effect on working memory and brain blood flow by ingestion of ginkgo biloba in healthy volunteers

Acronym

Effect on working memory and brain blood flow by ginkgo biloba

Scientific Title

Effect on working memory and brain blood flow by ingestion of ginkgo biloba in healthy volunteers

Scientific Title:Acronym

Effect on working memory and brain blood flow by ginkgo biloba

Region

Japan


Condition

Condition

deterioration of memory, memory loss

Classification by specialty

Geriatrics Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the association between working memory and blood flow in brain by taking a single dose of ginkgo biloba preparation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

working memory and blood flow in brain by using Near Infrared Spectroscopy (NITS)

Key secondary outcomes

blood concentraion of ginkgolide A, B, bilobalide


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration


Blocking

YES

Concealment

No need to know


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

placebo

Interventions/Control_2

Ginkgo biloba 120mg

Interventions/Control_3

Ginkgo biloba 240mg

Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

30 years-old >=

Gender

Male and Female

Key inclusion criteria

1. male and female, healthy volunteers
2. the dominant hand is the right underling
3. Nonsmoker

Key exclusion criteria

1.The person who has an anamnesis of hypersensitivity to the active ingredient of ginkgo biloba preparation and this agent
2.The person who took alcohol and medicine, a drink (coffee, energy support drink) containing caffeine within 12 hours
3.The person who uses OTC medicines and prescription medicine routinely
4.Person who does not get enough sleep on the day before
5.The person who ate and drank within two hours prior to start of study

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mayumi Mochizuki

Organization

Keio University

Division name

Faculty of Pharmacy

Zip code


Address

1-5-30, Shibakouen, Minato-ku, Tokyo

TEL

03-5400-2120

Email

mochizuki-my@pha.keio.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masayuki Hashiguchi

Organization

Keio University

Division name

Faculty of Pharmacy

Zip code


Address

1-5-30, Shibakouen, Minato-ku, Tokyo

TEL

03-5400-2120

Homepage URL


Email

hashiguchi-ms@pha.keio.ac.jp


Sponsor or person

Institute

Keio University

Institute

Department

Personal name



Funding Source

Organization

Keio University

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Medical Co.LTA

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 02 Month 25 Day

Date of IRB


Anticipated trial start date

2015 Year 03 Month 02 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 02 Month 24 Day

Last modified on

2018 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019230


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name