UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038774 |
|---|---|
| Receipt number | R000044204 |
| Scientific Title | Analysis of effects of essential oil exposure on cognitive function in simulated bathing environment |
| Date of disclosure of the study information | 2019/12/03 |
| Last modified on | 2020/12/02 12:30:19 |
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Basic information
Public title
Analysis of the effect of essential oil scent on cognitive function in a simulated bathroom environment
Acronym
Effects of essential oils on cognitive function
Scientific Title
Analysis of effects of essential oil exposure on cognitive function in simulated bathing environment
Scientific Title:Acronym
Effects of essential oil exposure on cognitive function
Region
| Japan |
Condition
Condition
Healthy young adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using essential oils (1,8-cineole) with known efficacy, observing the effect of differences in the method of exposure to fragrance on concentration transition, volatilizing exposure like general aromatherapy, Compare performance related to cognitive function with exposure in the form of bath additives.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Paced Auditory Serial Addition test(Immediately after exposure to essential oil)
Key secondary outcomes
Miyake Memory test,
1 minute word recall task
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Resting position(Only 20 minutes at a time)
Interventions/Control_2
Put only the head in the enclosed space(Only 20 minutes at a time)
Interventions/Control_3
Place only essential oil in the enclosed space(Only 20 minutes at a time, 1 ppm of 1,8-cineole)
Interventions/Control_4
Drop essential oil in a hot water container and stir with a water pump(Only 20 minutes at a time, 1 ppm of 1,8-cineole)
Interventions/Control_5
Stir the container with hot water with a water pump(Only 20 minutes at a time, 1 ppm of 1,8-cineole)
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
Adults with no abnormal olfaction
Key exclusion criteria
History of sinusitis or chronic illness
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Jun-ichi |
| Middle name | |
| Last name | Iiyama |
Organization
Kumamoto Health Science University
Division name
Department of Health Science
Zip code
861-5598
Address
325 Izumi-machi, Kita-ku, Kumamoto, Japan
TEL
096-275-2111
iiyama@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Jun-ichi |
| Middle name | |
| Last name | Iiyama |
Organization
Kumamoto Health Science University
Division name
Department of Health Science
Zip code
861-5598
Address
325 Izumi-machi, Kita-ku, Kumamoto, Japan
TEL
096-275-2111
Homepage URL
iiyama@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
Not applicable
Address
Not applicable
Tel
096-275-2111
iiyama@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
| 2019 | Year | 12 | Month | 03 | 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
10
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
| 2019 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 10 | 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
| 2019 | Year | 12 | Month | 03 | Day |
Last modified on
| 2020 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044204
