UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057965 |
|---|---|
| Receipt number | R000066269 |
| Scientific Title | Optimal Temperature Survey on Temperature and Thermal Stimulation Sensation of Electric Moxibustion Apparatus |
| Date of disclosure of the study information | 2025/05/27 |
| Last modified on | 2025/09/20 12:34:36 |
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Basic information
Public title
Optimal Temperature Survey on Temperature and Thermal Stimulation Sensation of Electric Moxibustion Apparatus
Acronym
Optimal Temperature Survey on Temperature and Thermal Stimulation Sensation of Electric Moxibustion Apparatus
Scientific Title
Optimal Temperature Survey on Temperature and Thermal Stimulation Sensation of Electric Moxibustion Apparatus
Scientific Title:Acronym
Optimal Temperature Survey on Temperature and Thermal Stimulation Sensation of Electric Moxibustion Apparatus
Region
| Japan |
Condition
Condition
No name of target disease
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to use an electronic onkyu apparatus (Murata Manufacturing Co., Ltd., ceramic electric onkyu apparatus) to identify comfortable temperatures.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Six-level survey on thermal sensation (0 not at all hot to 6 too hot to tolerate)
Seven-level survey on temperature pleasantness (0 very unpleasant to 7 very pleasant)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention with the electronic warm moxa device set at 43 temperature for 3 seconds 3 sets of stimulation on 5 areas
back of right hand, right lower leg, right lower back, abdomen , and upper right shoulder .
Interventions/Control_2
Intervention with the electronic warm moxa device set at 46 temperature for 3 seconds 3 sets of stimulation on 5 areas
back of right hand, right lower leg, right lower back, abdomen , and upper right shoulder .
Interventions/Control_3
Intervention with the electronic warm moxa device set at 49 temperature for 3 seconds 3 sets of stimulation on 5 areas
back of right hand, right lower leg, right lower back, abdomen , and upper right shoulder .
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
| 22 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Selection should be based on the experience of moxibustion stimulation in order to determine the comfortable temperature and stimulation, including comparison with general moxibustion treatment and moxibustion stimulation.
Key exclusion criteria
Exclusion criteria are moxibustion treatment, no experience with moxibustion stimulation, impaired temperature sensation, and inflammatory signs such as heat swelling at the stimulation site.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | yusuke |
| Middle name | |
| Last name | murakoshi |
Organization
Niigata University of health and welfare
Division name
Department of Acupucntre and moxibustion
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, JAPAN
TEL
0252574455
yusuke-murakoshi@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | yusuke |
| Middle name | |
| Last name | murakoshi |
Organization
Niigata University of health and welfare
Division name
Department of Acupucntre and moxibustion
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, JAPAN
TEL
0252574455
Homepage URL
yusuke-murakoshi@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
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, JAPAN
Tel
0252574455
yusuke-murakoshi@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 | 05 | Month | 27 | 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
| 2025 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 20 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 20 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066269
