UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect on working memory and brain blood flow by ingestion of ginkgo biloba in healthy volunteers
Title of the study (Brief title)	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	Mayumi Mochizuki
Organization	Keio University
Division name	Faculty of Pharmacy
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	Masayuki Hashiguchi
Organization	Keio University
Division name	Faculty of Pharmacy
Address	1-5-30, Shibakouen, Minato-ku, Tokyo
TEL	03-5400-2120
Homepage URL
Email	hashiguchi-ms@pha.keio.ac.jp

Sponsor
Institute	Keio University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019230