UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056954 |
|---|---|
| Receipt number | R000065083 |
| Scientific Title | Effects of activation of TRPM8 in human skin on thermal sensation and circulatory responses related with cold acclimation |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/12/10 17:43:46 |
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Basic information
Public title
Effects of activation of TRPM8 in human skin on thermal sensation and circulatory responses related with cold acclimation
Acronym
Effects of activation of TRPM8 on thermoregulatory responses
Scientific Title
Effects of activation of TRPM8 in human skin on thermal sensation and circulatory responses related with cold acclimation
Scientific Title:Acronym
Effects of activation of TRPM8 on thermoregulatory responses
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of activating TRPM8 on changes in thermal sensation and circulatory responses associated with cold acclimation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate, arterial blood pressure, skin blood flow, thermal sensation, thermal comfort
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Immersion of forearm in cold water (20C)
Interventions/Control_2
10% menthol application
Interventions/Control_3
10% menthol application and immersion of forearms in cold water (20C)
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
No respiratory disease, no regular medication, no smoking history, not a water-based activity participant
Key exclusion criteria
Respiratory diseases, those with a history of taking daily medication or smoking, and those who engage in water-based activities
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Fujimoto |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
9503198
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL
0252574675
fujimoto@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Fujimoto |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
9503198
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL
0252574675
Homepage URL
fujimoto@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Tomomi Fujimoto
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
Tel
0252574675
fujimoto@nuhw.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
| 2025 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 02 | Month | 06 | Day |
Last modified on
| 2025 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065083
