UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047749 |
|---|---|
| Receipt number | R000054433 |
| Scientific Title | Effects of menthol-induced activation of TRPM8 on heat and cold-evoked potentials |
| Date of disclosure of the study information | 2022/05/13 |
| Last modified on | 2023/01/17 17:18:42 |
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Basic information
Public title
Effects of menthol-induced activation of TRPM8 on heat and cold-evoked potentials
Acronym
Effects of activation of TRPM8 on heat and cold-evoked potentials
Scientific Title
Effects of menthol-induced activation of TRPM8 on heat and cold-evoked potentials
Scientific Title:Acronym
Effects of activation of TRPM8 on heat and cold-evoked potentials
Region
| Japan |
Condition
Condition
Healthy college student
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify how TRPM8 is involved in temperature sensitivity.
Basic objectives2
Others
Basic objectives -Others
Clarify how activation of TRPM8 affects thermal and pain sensations
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin warm and cool sensitivity
Skin heat and cold pain sensitivity
Heat and cold-evoked potentials
Numeric Rating Scale
Key secondary outcomes
Skin temperature
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Application of 10% menthol solution (solvent 2% dimethyl sulfoxide and 88% propylene glycol)
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult men and women without skin or brain diseases
Key exclusion criteria
Those with a history of skin or brain disease
Target sample size
20
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
950-3198
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL
025-257-4675
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
950-3198
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL
09085674803
Homepage URL
fujimoto@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
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
025-257-4675
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
| 2022 | Year | 05 | Month | 13 | 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
| 2022 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 05 | Month | 13 | Day |
Last modified on
| 2023 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054433
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
