UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058474 |
|---|---|
| Receipt number | R000066544 |
| Scientific Title | A verification study on the psychological and physiological effects of aroma inhalation |
| Date of disclosure of the study information | 2026/07/15 |
| Last modified on | 2026/01/07 10:47:42 |
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Basic information
Public title
A verification study on the psychological and physiological effects of aroma inhalation
Acronym
A verification study on the psychological and physiological effects of aroma inhalation
Scientific Title
A verification study on the psychological and physiological effects of aroma inhalation
Scientific Title:Acronym
A verification study on the psychological and physiological effects of aroma inhalation
Region
| Japan |
Condition
Condition
female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify psychological and physiological effects of the test aroma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pupillary light reflex with Iriscorder Dual
Key secondary outcomes
Subjective questionnaire, Skin temperature, Brain activity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
Inhale the aroma of the test product for 2 minutes under spontaneous respiration at the designated time.
Interventions/Control_2
Inhale the aroma of the placebo product for 2 minutes under spontaneous respiration at the designated 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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1. Female aged 20 to below 50 years at the time of consent acquisition.
2. Individuals with a body mass index (BMI) of 18.5 kg/m2 or higher and less than 25.0 kg/m2.
3. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria
1. Individuals who dislike citrus or woody scents.
2. Individuals with a smoking habit (except those who have abstained from smoking for more than six months).
3. Individuals who are currently taking pharmaceuticals, Foods for Specified Health Uses, Foods with Function Claims (e.g., GABA), or health foods (including supplements) that may affect the study outcomes.
4. Individuals with eye conditions (e.g., exotropia, esotropia, ptosis) or eyelash shapes that are unsuitable for pupillary measurement.
5. Individuals with conditions that interfere with pupillary measurement, such as dry eye.
6. Individuals with self-reported claustrophobia or nyctophobia.
7. Individuals who experience frequent daytime sleepiness or have irregular sleep patterns, such as night shift workers.
8. Individuals who are continuously taking therapeutic medications.
9. Individuals who are sensitive to cold (including those who feel cold in their extremities even during summer).
10. Individuals with nasal congestion due to allergic rhinitis or those who are unable to distinguish scents.
11. Individuals with injuries at the measurement site.
12. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
13. Individuals with dermatological conditions such as atopic dermatitis.
14. Individuals with chemical sensitivity or allergies to essential oils, alcohol, or synthetic fragrances.
15. Individuals with previous or current medical history of serious diseases in the heart, liver, kidney, digestive organs.
16. Individuals who are pregnant, breastfeeding, or intending to become pregnant during trial period.
17. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
SUZUKI MOTOR CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
S.T. CORPORATION
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
| 2026 | Year | 07 | Month | 15 | 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
Completed
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066544
