UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057916 |
|---|---|
| Receipt number | R000066181 |
| Scientific Title | Verification of effects on autonomic nervous system, by inhalation of test products-including aroma |
| Date of disclosure of the study information | 2026/05/21 |
| Last modified on | 2025/10/24 16:58:34 |
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Basic information
Public title
Verification of effects on autonomic nervous system, by inhalation of test products-including aroma
Acronym
Verification of effects on autonomic nervous system, by inhalation of test products-including aroma
Scientific Title
Verification of effects on autonomic nervous system, by inhalation of test products-including aroma
Scientific Title:Acronym
Verification of effects on autonomic nervous system, by inhalation of test products-including aroma
Region
| Japan |
Condition
Condition
Healthy female volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the physiological and psychological effects of using fragrances containing synthetic fragrances as air fresheners in women aged 20 to 49 years old, using a placebo fragrance as a control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pupillary light reflex
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
Smell the test products-including aromas
Interventions/Control_2
Smell the control product
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
Female
Key inclusion criteria
(1) Women aged 20 to 50 at the time of obtaining informed consent
(2) Those with a BMI of 18.5 or more and less than 25.0 kg/m2
(3) Individuals who have received a sufficient explanation of the study, can understand the contents, and can give their own informed consent
Key exclusion criteria
(1) People who dislike citrus scents such as lemon, herbal scents such as lavender and eucalyptus, and woody scents such as incense and cypress.
(2) People who have a habit of smoking (excluding those who have quit smoking for more than six months)
(3) Those taking foods for specified health uses, foods with functional claims (GABA, lactobacillus drinks for stress relief, etc.), health foods (including supplements), etc. that may affect the study
(4) Persons whose eyes (exotropia, esotropia, ptosis, etc.) or eyelashes are not suitable for pupil measurement
(5) Persons who have dry eyes or other conditions that impede pupil measurement
(6) Persons who are aware of claustrophobia or nyctophobia
(7) Persons who are aware of daily daytime sleepiness or who have irregular sleep hours due to night shifts, etc.
(8) People who are taking medications on an ongoing basis
(9) People who are aware of poor circulation (including people who feel cold hands and feet even in summer)
(10) People who have stuffy noses due to allergic rhinitis, or who cannot distinguish between scents
(11) Persons with external wound at the measurement site
(12) Persons currently participating in clinical trials of other drugs or health foods, or who have completed the trial within 4 weeks
(13) Persons with symptoms of skin diseases such as atopic dermatitis
(14) Persons with a history or current history of serious diseases of the heart, liver, kidneys, digestive system, etc.
(15) Persons who are pregnant, wish to become pregnant, or are breastfeeding
(16) Individuals with chemical sensitivity or allergies to essential oils, alcohol, or synthetic fragrances
(17) Individuals who have experienced or may experience nausea from the smell of alcohol or synthetic fragrances
(18) Individuals who are deemed inappropriate for participation in this study by the principal investigator, etc.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Sakamoto |
Organization
KOBAYASHI Pharmaceutical Co.,Ltd.
Division name
Personal & House Care Product Development Dpmt R&D Headquarters
Zip code
567-0057
Address
1-30-3,Toyokawa,Ibaraki-city,Osaka 567-0057 Japan
TEL
080-3459-9170
k.sakamoto@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Tanaka |
Organization
KOBAYASHI Pharmaceutical Co.,Ltd.
Division name
Personal & House Care Product Development Dpmt R&D Headquarters
Zip code
567-0057
Address
1-30-3,Toyokawa,Ibaraki-city,Osaka 567-0057 Japan
TEL
080-3499-6257
Homepage URL
yur.tanaka@kobayashi.co.jp
Sponsor or person
Institute
KOBAYASHI Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiyoda Paramedical Care Clinic Ethics Committee
Address
3-3-10,Hongoku-cho,Nihonbashi,Chuo-ku,Tokyo 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 | 05 | Month | 21 | 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 | 04 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 23 | 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 | 05 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066181
