UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060043 |
|---|---|
| Receipt number | R000068666 |
| Scientific Title | Effects of Topical Capsaicin Application to the Thigh on Quadriceps Muscle Function and Blood Flow |
| Date of disclosure of the study information | 2025/12/10 |
| Last modified on | 2025/12/10 20:47:35 |
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Basic information
Public title
Effects of Topical Capsaicin Application to the Thigh on Quadriceps Muscle Function and Blood Flow
Acronym
Effects of Topical Capsaicin Application on Quadriceps Muscle Function and Blood Flow
Scientific Title
Effects of Topical Capsaicin Application to the Thigh on Quadriceps Muscle Function and Blood Flow
Scientific Title:Acronym
Effects of Topical Capsaicin Application on Quadriceps Muscle Function and Blood Flow
Region
| Japan |
Condition
Condition
Halthy young adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of topical capsaicin application to the thigh on quadriceps muscle function and blood flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle temperature, Femoral arterial blood flow, Maximal muscle strength, Muscle activity (EMG amplitude)
Key secondary outcomes
ublingual temperature, Ratings of perceived exertion (RPE), Thermal sensation, Thermal comfort
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
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Topical capsaicin application to the thigh
Interventions/Control_2
Topical application of a control solution (vehicle without capsaicin) to the thigh
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
Key inclusion criteria
University undergraduate or graduate students who express interest in the study and voluntarily consent to participate. Eligible participants must have no neuromuscular, internal, or orthopedic disorders; no habitual medication use or smoking history; and must not belong to a university athletic club.
Key exclusion criteria
Individuals with neuromuscular, internal, or orthopedic disorders; individuals with habitual medication use or a smoking history; and individuals belonging to a university athletic club.
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
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
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 | 12 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2028 | 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 | 12 | Month | 10 | 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=R000068666
