UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051972 |
|---|---|
| Receipt number | R000059252 |
| Scientific Title | Exploratory research on the functionality of fragrances |
| Date of disclosure of the study information | 2023/08/24 |
| Last modified on | 2025/01/20 14:16:47 |
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Basic information
Public title
Exploratory research on the functionality of fragrances
Acronym
Exploratory research on the fragrances
Scientific Title
Exploratory research on the functionality of fragrances
Scientific Title:Acronym
Exploratory research on the fragrances
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze the composition of blended fragrances (fragrances blended with artificially synthesized fragrances the name of white musk).
Basic objectives2
Others
Basic objectives -Others
Verify the effects of the fragrance formulation on humans.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Profile of Mood States 2nd Edition Visual Analogue Scale(Fragrance impressions and preferences),
EEG measurement,Electro-cardiogram
Key secondary outcomes
Stress Assessment(Amylase in saliva)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Blended fragrances
Interventions/Control_2
Unscented space
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1Applicants whose native language is Japanese
2Who will refrain from wearing clothes with fabric softener,perfume,or perfumed hairdressing products on the day of the examination.
Key exclusion criteria
1Those who have a smoking habit
2Those who have symptoms such as olfactory disorder or rhinitis
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Faculty of Agriculture,Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
819-0395
Address
744 Motooka,Nishiku-Fukuoka,Fukuoka,Japan
TEL
0928024675
shimizu.kuniyoshi.381@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Ishizawa |
Organization
Faculty of Agriculture,Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
819-0395
Address
744 Motooka,Nishiku-Fukuoka,Fukuoka,Japan
TEL
0928024675
Homepage URL
ishizawa.yuka.226@m.kyushu-u.ac.jp
Sponsor or person
Institute
Faculty of Agriculture,Kyushu University
Institute
Department
Personal name
Kuniyoshi Shimizu
Funding Source
Organization
The Next Day Inc.
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
Ethics Committee of Graduate School of Agriculture, Kyushu University
Address
744 Motooka,Nishiku-Fukuoka,Fukuoka,Japan
Tel
092-802-4506
norsenryaku@jimu.kyushu-u.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
| 2023 | Year | 08 | Month | 24 | 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
Main results already published
Date of protocol fixation
| 2023 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 24 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 29 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 31 | Day |
Other
Other related information
Zennifa, F., Nakashima, T., Xu, Y. et al. A pilot study on the effects of olfactory stimulation with white musk aromatic oil on psychophysiological activity: a crossover study. Sci Rep 15, 1723 (2025). https://doi.org/10.1038/s41598-024-83887-2
Management information
Registered date
| 2023 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059252
