UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050060 |
|---|---|
| Receipt number | R000057030 |
| Scientific Title | Contribution of TRP channels on cardiovascular responses to cold pressor test |
| Date of disclosure of the study information | 2023/01/18 |
| Last modified on | 2024/02/01 08:40:52 |
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Basic information
Public title
Contribution of TRP channels on cardiovascular responses to cold pressor test
Acronym
Contribution of skin thermoreceptor on cardiovascular responses to cold stimulus
Scientific Title
Contribution of TRP channels on cardiovascular responses to cold pressor test
Scientific Title:Acronym
Contribution of skin thermoreceptor on cardiovascular responses to cold stimulus
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we investigate the effects of activation of the human skin cold receptors TRPM8, TRPA1 and TRPV1 by the drugs menthol and cinnamaldehyde on the cardiovascular response and pain sensation induced by cold pressor test. The objective of this study was to clarify the role of the skin thermoreceptors TRPM8, TRPA1 and TRPV1 in the cardiovascular response induced by cold stimuli.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Arterial pressure, pain sensation, autonomic nervous activity
Key secondary outcomes
Heart rate, cardiac output, stroke volume, total peripheral resistance
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Application of menthol solution to the forearm skin
Interventions/Control_2
Application of cinnamaldehyde solution to the forearm skin
Interventions/Control_3
Application of control solution to the forearm skin
Interventions/Control_4
Application of capsaicine solution to the forearm skin
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 or skin diseases, no daily medication and no history of smoking
Key exclusion criteria
Have any of the following: respiratory disease, skin disease, or have a history of daily medication and smoking
Target sample size
15
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
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
950-3198
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL
0252574675
Homepage URL
fujimoto@nuhw.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Tomomi Fujimoto
Funding Source
Organization
Others
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
| 2023 | Year | 01 | Month | 18 | 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
10
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 | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 01 | Month | 17 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057030
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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