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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030569
Receipt No. R000034903
Scientific Title Study of effects of Ninjin'yoeito on cerebral cortical blood flow (Randomized cross-over study)
Date of disclosure of the study information 2017/12/26
Last modified on 2019/08/21

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Basic information
Public title Study of effects of Ninjin'yoeito on cerebral cortical blood flow (Randomized cross-over study)
Acronym Study of effects of Ninjin'yoeito on cerebral cortical blood flow
Scientific Title Study of effects of Ninjin'yoeito on cerebral cortical blood flow (Randomized cross-over study)
Scientific Title:Acronym Study of effects of Ninjin'yoeito on cerebral cortical blood flow
Region
Japan

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

Objectives
Narrative objectives1 To investigate whether or not Ninjin'yoeito affects cerebral cortical blood flow, depression and anxiety.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cerebral cortical blood flow
Key secondary outcomes Depression, anxiety

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of 3.75g of Ninjin'yoeito dissolved in 200cc of distilled water <Washout period : 1 week> Oral administration of 200cc of distilled water
Interventions/Control_2 Oral administration of 200cc of distilled water <Washout period : 1 week> Oral administration of 3.75g of Ninjin'yoeito dissolved in 200cc of distilled water
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
20 years-old <=
Age-upper limit
40 years-old >
Gender Male
Key inclusion criteria Healthy adult males without serious past illnesses.
Key exclusion criteria 1.Subjects who are judged as unsuitable for the study by the medical doctor in attendance because of a large burden on the mind and body.

2.Subjects who are judged to be difficult to participate in this study because of psychiatric disorders and symptoms.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiro Asakawa
Organization Kagoshima University Hospital
Division name Respiratory and Stress Care Center, Psychosomatic Medicine
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima-city, Kagoshima, JAPAN
TEL 099-275-5751
Email asakawa@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Asakawa
Organization Kagoshima University Hospital
Division name Respiratory and Stress Care Center, Psychosomatic Medicine
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima-city, Kagoshima, JAPAN
TEL 099-275-5751
Homepage URL
Email asakawa@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Hospital
Respiratory and Stress Care Center
Psychosomatic Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
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 鹿児島大学病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 26 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 Terminated
Date of protocol fixation
2017 Year 05 Month 26 Day
Date of IRB
2017 Year 07 Month 03 Day
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 26 Day
Last modified on
2019 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034903

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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