UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029702 |
|---|---|
| Receipt number | R000033698 |
| Scientific Title | Psycological/physiological response evaluation by application of aroma components |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2021/11/22 17:41:32 |
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Basic information
Public title
Psycological/physiological response evaluation by application of aroma components
Acronym
Psycological/physiological response evaluation by application of aroma components
Scientific Title
Psycological/physiological response evaluation by application of aroma components
Scientific Title:Acronym
Psycological/physiological response evaluation by application of aroma components
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of aroma associated with the cold sensation stimulus on psychological / physiological response.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cold sensation threshold change within 10 minutes after application of aroma components.
Key secondary outcomes
The probe temperatures and heats flux when the subject feels cold.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The test is carried out once per person, on three samples.
While keeping a certain interval, the subject is applied the cosmetic gel containing aroma components to the forearm 2.5 cm square for 5 to 10 minutes for each sample.
Interventions/Control_2
To repeat heating and cooling (in the range of approximately 25 to 35 degrees C ) the forearm (gel application part) 5 times (1 to 2 minutes each time) per sample with a temperature-variable probe.
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
| 24 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)Japanese
(2)Female
(3)Age:20-24, Healthy person
(At obtaining informed consent)
(4)Persons giving written informed consent
Key exclusion criteria
(1) Subjects who are sensitive to scent and may cause indefinite complaints or asthma.
(2) Subjects who cause skin allergy symptoms (rash, redness, itching etc) by medicine or cosmetics and those with cutaneous hypersensitivity.
(3) Subjects who have diseases related to blood circulation disorder.
(4) Subjects with a declining thermal sensation or those with excessive sensitivity.
(5) Subjects who use topical cream on their forearms.
(6) Subjects who have skin symptoms around the site of observation (forearm) that affect the evaluation. For example, scratches, pimples, etc.
(7) Subjects who currently go to dermatology office.
(8) Subjects who are pregnant, may be pregnant in near future, or are breast-feeding.
(9) Subjects who participate in other clinical studies.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Rie |
| Middle name | |
| Last name | Yamashita |
Organization
Industrial Research Institute of Shizuoka Prefecture
Division name
Food Science and Technology
Zip code
421-1298
Address
2078 Makigaya, Aoi-ku, Shizuoka-city, Shizuoka, 421-1298, Japan
TEL
+81-054-278-3024
rie1_yamashita@pref.shizuoka.lg.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Yamashita |
Organization
Industrial Research Institute of Shizuoka Prefecture
Division name
Food Science and Technology
Zip code
421-1298
Address
2078 Makigaya, Aoi-ku, Shizuoka-city, Shizuoka, 421-1298, Japan
TEL
+81-054-278-3024
Homepage URL
rie1_yamashita@pref.shizuoka.lg.jp
Sponsor or person
Institute
Industrial Research Institute of Shizuoka Prefecture
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Board of Industrial Research Institute of Shizuoka Prefecture
Address
2078 Makigaya, Aoi-ku, Shizuoka-city, Shizuoka, 421-1298, Japan
Tel
+81-054-278-3028
rie1_yamashita@pref.shizuoka.lg.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
| 2017 | Year | 11 | Month | 01 | 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
| 2017 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 25 | Day |
Last modified on
| 2021 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033698
