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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016618
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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