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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023990
Receipt No. R000027614
Scientific Title Efficacy study of oral Ginkgo biloba extract to improve brain function for the middle aged and elderly
Date of disclosure of the study information 2016/09/09
Last modified on 2017/03/13

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Basic information
Public title Efficacy study of oral Ginkgo biloba extract to improve brain function for the middle aged and elderly
Acronym Efficacy study of oral Ginkgo biloba extract to improve brain function
Scientific Title Efficacy study of oral Ginkgo biloba extract to improve brain function for the middle aged and elderly
Scientific Title:Acronym Efficacy study of oral Ginkgo biloba extract to improve brain function
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare and evaluate the effect of a test food on brain function before and after ingestion of the test food or placebo
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rey Auditory Verbal Learning Test, Standard verbal paired-associate learning test, Paced Auditory Serial Addition Test
Key secondary outcomes Stroop test

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 The treatment group will receive oral administration of three tablets including 168 mg Ginkgo biloba extract.
Interventions/Control_2 The placebo group will receive oral administration of three Ginkgo biloba extract-free tablets
Interventions/Control_3
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
45 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria 1) Men and women aged from 45 to 69
2) Subjects with self-awareness of forgetfulness
3) Subjects with inferior scores of brain function tests
Key exclusion criteria 1) Subjects who are difficult to discriminate color
2) Subjects with bad eyesight, or are diagnosed with amblyopia or blindness
3) Subjects with bad hearing, or are diagnosed with hearing loss or permanent hearing loss
4) Subjects who get a score of 20 or less on the Revised HDS-R
5) Subjects with history of cranial nerve disease
6) Subjects who have depressive symptoms, or who have been diagnosed as depressive disorder
7) Subjects who are under hormone treatment or are diagnosed with menopause
8) Subjects who have some irregular schedules during the study, due to night work or something
9) Subjects who drink much alcohol
10) Subjects who smoke, or quit smoking within one year before pre-inspection
11) Subjects who have done the same brain function test before
12) Subjects who are under treatment of brain functions, or are prescribed with medicine for them
13) Subjects who continuously take medicine, health foods, Food for Specified Health Uses or Foods with Function Claims including substance related to brain functions
14) Subjects who was given or donated 200 ml or 400 ml whole blood within three months before pre-inspection
15) Subjects who participated in other study within one month before pre-inspection, or are going to participate in other study during the study
16) Subjects who have a disease which needs regular medication, or have a history of the disease
17) Subjects who are judged as unsuitable for the study by investigator because of clinical test, anthropometric test and physical examination in pre-inspection
18) Subjects who are in danger of allergy to the study
19) Subjects who are taking warfarin in the brain infarction or heart or need to take warfarin during the study
20) Subjects who are pregnant or lactating, or plan to become pregnant or lactate during the study
21) Subjects who are judged as unsuitable for the study because of lifestyle questionnaire
22) Subjects who are judged as unsuitable for the study by investigator for other reasons
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuji Tabata
Organization Itty, INC.
Division name None
Zip code
Address 1-27-7, Higashi, Shibuya-ku, TOKYO, 150-0011 JAPAN
TEL 03-6418-4875
Email tabata@itty.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kotoha Isobe
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
Address 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email k.isobe@ttc-tokyo.co.jp

Sponsor
Institute Itty, INC.
Institute
Department

Funding Source
Organization Itty, INC.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 医療法人健昌会 福島健康管理センター

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 09 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
2016 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 10 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
2016 Year 09 Month 09 Day
Last modified on
2017 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027614

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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