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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031904
Receipt No. R000036428
Scientific Title Influence of "Soshinmei" drink containing ginkgo biloba extract on cerebral blood flow
Date of disclosure of the study information 2018/04/01
Last modified on 2020/01/20

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Basic information
Public title Influence of "Soshinmei" drink containing ginkgo biloba extract on cerebral blood flow
Acronym Influence of drink containing ginkgo biloba extract on cerebral blood flow
Scientific Title Influence of "Soshinmei" drink containing ginkgo biloba extract on cerebral blood flow
Scientific Title:Acronym Influence of drink containing ginkgo biloba extract on cerebral blood flow
Region
Japan

Condition
Condition Healthy people belonging to qi deficiency or qi stagnation in the TCM quality table
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Major ingredients of ginkgo biloba extract include flavonoids and ginkgolides. Flavonoids have several functions such as dilatation of vessel s, improvement of arteriosclerosis, Antispasmodic action and normalization of blood glucose level. Ginkgolides can mainly improve peripheral microcirculation, especially has a good function of improving cerebral and peripheral vascular circulation. Therefore, improvement of dementia, hypertension, tinnitus, neuralgia, polyuria, coldness, and allergies. In this study, a non-invasive examination device, NIRS is used to observe the effect of drink containing ginkgo leaf extract on cerebral blood flow.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes of hemoglobin concentration in the anterior cortex 1 hour after taking the drink containing ginkgo biloba extract
Key secondary outcomes Changes of condition based on the Japanese version of Chinese Medicine Quality Inquiry Form(CCMQ-J)
Changes of subjective symptoms(NRS)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Single intake of 50 ml of "Soshinmei" drink that contains curcumin, gingko leaf extract, carnitine, pickpea extract, glycosyl transfer hesperidin
Interventions/Control_2
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy people belonging to qi deficiency or qi stagnation in the Japanese CCMQ-J
Key exclusion criteria Persons who visit psychiatric or psychosomatics department
Persons taking psychotropics (antipsychotics, anxiolytics, antidepressants, antimanics, sleep induction drugs, etc.)
Persons who have a history of cerebrovascular diseases
Persons who continuously take health food for stress
Persons taking antiplatelet drugs, anticoagulants (warfarin etc.) during the test period
Persons who are easy to bleed
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Ko
Middle name
Last name Nishimura
Organization Suzuka University of Medical Science
Division name Institute of Traditional Chinese Medicine
Zip code 510-0226
Address 1275-3, Kishioka, Suzuka-city, Mie, 510-0226, JAPAN
TEL 059-381-2385
Email ko-n@suzuka-u.ac.jp

Public contact
Name of contact person
1st name Ken
Middle name
Last name Takagi
Organization Suzuka University of Medical Science
Division name Institute of Traditional Chinese Medicine
Zip code 510-0226
Address 1275-3, Kishioka, Suzuka-city, Mie, 510-0226, JAPAN
TEL 059-381-2385
Homepage URL
Email Takagi17@suzuka-u.ac.jp

Sponsor
Institute Suzuka University of Medical Science
Institute of Traditional Chinese Medicine
Institute
Department

Funding Source
Organization Zenyaku Kogyo Co., Ltd.
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 Institute of Traditional Chinese Medicine, Suzuka University of Medical Science
Address 1275-3, Kishioka, Suzuka-city, Mie, 510-0226, JAPAN
Tel 059-381-2385
Email ko-n@suzuka-u.ac.jp

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
2018 Year 04 Month 01 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 47
Results
Integrated value of oxygenated hemoglobin in the frontal lobe by NIRS at 1 hour after intake of drink containing ginkgo biloba extract significantly decreased. Yang deficiency, yin deficiency, sputum wet, wet heat, and blood stagnation constitutions significantly improved after intake. As for subjective symptoms, physical fatigue and mental symptoms significantly improved. There were no adverse events with drinking.
Results date posted
2020 Year 01 Month 20 Day
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
2018 Year 03 Month 20 Day
Date of IRB
2018 Year 02 Month 28 Day
Anticipated trial start date
2018 Year 04 Month 06 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 26 Day
Last modified on
2020 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036428

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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