UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047510 |
|---|---|
| Receipt number | R000054125 |
| Scientific Title | Evaluation of autonomic and central nervous activities, before and after inhalation of odors of Japanese fragrance materials. |
| Date of disclosure of the study information | 2023/04/19 |
| Last modified on | 2023/04/21 12:39:31 |
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Basic information
Public title
Evaluation of autonomic and central nervous activities, before and after inhalation of odors of Japanese fragrance materials.
Acronym
Evaluation of autonomic and central nervous activities, before and after inhalation of odors of Japanese fragrance materials.
Scientific Title
Evaluation of autonomic and central nervous activities, before and after inhalation of odors of Japanese fragrance materials.
Scientific Title:Acronym
Evaluation of autonomic and central nervous activities, before and after inhalation of odors of Japanese fragrance materials.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify some kind of operation on psychology, the autonomic and central nervous activities, which could be induced by inhalation of odors of the fragrances extracted from Japanese-made plants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the autonomic and central nervous system
Key secondary outcomes
1. Visual analog scale questionnaire
2. Multiple measurements of emotion using a multiple mood scale
3. Preference assessment
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Inhalation of the test fragrance under natural respiration.
Interventions/Control_2
Inhalation of the placebo (an odorless air) under natural respiration.
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
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy adult subjects, not less than 20 but less than 45 years old, at the moment of giving informed consent to take part in this trial.
(2) Subjects who can give informed consent to participate in this trial, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects being poor at sniffing a wide variety of perfume materials.
(2) Subjects with the condition of being over-sensitiveness to cold, even during the summer season.
(3) Subjects who have suffered from some kind of disease within the last month into this trial, and being under medical treatment.
(4) Subjects who have undergone medical treatment for a pollinosis.
(5) Subjects having a stuffy nose just like allergic rhinitis, or having no way of smelling sense.
(6) Subjects having previous/present medical history of serious diseases in liver, kidney, heart, lung and blood.
(7) Pregnant, possibly pregnant, or lactating women.
(8) Subjects with some kind of skin symptom, disease or disorder, just like atopic dermatitis.
(9) Subjects who have undergone some kind of surgical treatment for the measurement region, within the last six months into this trial.
(10) Subjects who are now under other clinical tests with some kind of medicine/food, or took part in those within a month before this trial.
(11) Others who have been determined as ineligible for participation, judging from the investigator's opinions.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hisanori |
| Middle name | |
| Last name | Kenmotsu |
Organization
OGAWA & CO., LTD.
Division name
Material Research & Development Division
Zip code
300-0326
Address
7 Oaza-Hoshinosato, Amimachi, Inashiki-gun, Ibaraki 300-0326, Japan
TEL
029-875-5252
kenmotsu.hisanori@ogawa.net
Public contact
Name of contact person
| 1st name | Lanxi |
| Middle name | |
| Last name | Zhou |
Organization
OGAWA & CO., LTD.
Division name
Material Research & Development Division
Zip code
300-0326
Address
7 Oaza-Hoshinosato, Amimachi, Inashiki-gun, Ibaraki 300-0326, Japan
TEL
029-875-5252
Homepage URL
zhou.lanxi@ogawa.net
Sponsor or person
Institute
OGAWA & CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
OGAWA & CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Graduate School of Integrative and Global Majors, Tsukuba University
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
| 2023 | Year | 04 | Month | 19 | 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
| 2022 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 18 | Day |
Last modified on
| 2023 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054125
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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