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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038774
Receipt No. 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 2019/12/03

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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
Email 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
Email iiyama@kumamoto-hsu.ac.jp

Sponsor
Institute Kumamoto Health Science University
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2019 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044204

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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