UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030569 |
|---|---|
| Receipt number | 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 13:36:44 |
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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
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
asakawa@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital
Respiratory and Stress Care Center
Psychosomatic Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034903
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
