UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046206 |
|---|---|
| Receipt number | R000052734 |
| Scientific Title | Elucidation of the effect of 1,8-cineole inhalation on higher brain function in young adults and its mechanism |
| Date of disclosure of the study information | 2021/11/27 |
| Last modified on | 2023/05/29 14:22:52 |
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Basic information
Public title
Elucidation of the effect of essential oil inhalation on higher brain function in young adults and its mechanism
Acronym
Effects of essential oils on higher brain function in young adults
Scientific Title
Elucidation of the effect of 1,8-cineole inhalation on higher brain function in young adults and its mechanism
Scientific Title:Acronym
Effect of 1,8-cineole inhalation on higher brain function in young adults
Region
| Japan |
Condition
Condition
Young healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measurement of higher brain function in young adults by exposure to 1,8-cineole
Basic objectives2
Others
Basic objectives -Others
Elucidation of the mechanism of the effect of stimulation of olfactory receptors by 1,8-cineole
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG
Key secondary outcomes
P300 of the event-related potential, D-CAT, Stroop test
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Wearing an inspection mask with 1,8-cineole (7microL), 3 minutes, Single time
Interventions/Control_2
Wearing an inspection mask, 3 minutes, Single time
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
| 22 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women over the age of 20 who do not dislike the smell of 1,8-cineole
Key exclusion criteria
Those who have problems with the sense of smell due to chronic sinusitis, etc.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Jun-ichi |
| Middle name | |
| Last name | Iiyama |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Sciences
Zip code
8615598
Address
325 Izumi-machi, Kita-ku, kumamoto
TEL
096-275-2111
iiyama@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Kubo |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Sciences
Zip code
8615598
Address
325 Izumi-machi, Kita-ku, kumamoto
TEL
096-275-2111
Homepage URL
kubo@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
BATHCLIN CORPORATION
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
Kumamoto Health Science University
Address
325 Izumi-machi, Kita-ku, kumamoto
Tel
096-275-2111
kubo@kumamoto-hsu.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
| 2021 | Year | 11 | Month | 27 | 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
30
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
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 05 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 27 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052734
| 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 |
