UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062606 |
|---|---|
| Receipt number | R000071665 |
| Scientific Title | Effects of Moxibustion at Acupoints over Peripheral Arteries in the Extremities on Core Temperature, Skin Temperature, and Autonomic Nervous System Activity |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2026/09/17 08:49:22 |
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Basic information
Public title
Study of How Moxibustion on the Arms and Legs Affects Body Temperature and Autonomic Function
Acronym
META Study (Moxibustion on the Extremities: Effects on Temperature and Autonomic Activity)
Scientific Title
Effects of Moxibustion at Acupoints over Peripheral Arteries in the Extremities on Core Temperature, Skin Temperature, and Autonomic Nervous System Activity
Scientific Title:Acronym
META Study
Region
| Japan |
Condition
Condition
Healthy Volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
he objective of this study is to clarify the effects of moxibustion stimulation at acupoints located over arteries on the dorsum of the hands and feet on skin temperature, core temperature, and autonomic nervous system activity. In particular, the study aims to investigate the potential of these acupoints as effective stimulation sites and conditions for inducing a reduction in core temperature of at least 0.2 C.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Maximum reduction in core body temperature (tympanic temperature)
2.Proportion of participants with a 0.2 degree C or greater reduction in core body temperature
3.Cumulative duration of a 0.2 degree C or greater reduction in core body temperature
Key secondary outcomes
1.Changes in skin temperature at the peripheral extremities and subclavicular region
2.Changes in heart rate variability parameters, including the LF/HF ratio and HF power (high-frequency component; an index of parasympathetic nervous activity)
3.Changes in subjective sleepiness assessed using a Visual Analog Scale (VAS)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Moxibustion condition: Two moxa units (SenNenKyu Miracle Soft Smokeless Type) are applied to each of the following bilateral acupoints: LI4, LI5, SI5, LR3, ST42, and ST41. Participants ignite the moxa themselves and remove it when the warming sensation disappears. If excessive heat is perceived, the moxa is removed immediately. The intervention is performed once.
Interventions/Control_2
Control condition: Moxa units are applied to the bilateral LI4, LI5, SI5, LR3, ST42, and ST41 acupoints without ignition. The moxa units are attached for 9 minutes, replaced, and attached for an additional 9 minutes. The attachment duration is based on the average burning time of the moxa obtained in a preliminary experiment. The intervention is performed once.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Students or staff members of Morinomiya University of Medical Sciences
2.Healthy adults aged 18 to 65 years
3.Individuals who provide written informed consent after receiving a full explanation of the study
Key exclusion criteria
1.Individuals with sleep disorders
2.Individuals with cardiovascular diseases
3.Individuals with autonomic nervous system disorders
4.Individuals taking medications that may affect sleep or thermoregulation
5.Individuals judged by the investigators to be unsuitable for participation in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Matsukuma |
Organization
Morinomiya University of Medical Sciences
Division name
Department of Acupuncture, Faculty of Medical Science Technology
Zip code
559-8611
Address
1-26-16 Nankokita, Suminoe-ku, Osaka-shi, Osaka 559-8611, Japan
TEL
0666166911
matsukuma@morinomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Matsukuma |
Organization
Morinomiya University of Medical Sciences
Division name
Department of Acupuncture, Faculty of Medical Science Technology
Zip code
559-8611
Address
1-26-16 Nankokita, Suminoe-ku, Osaka-shi, Osaka 559-8611, Japan
TEL
0666166911
Homepage URL
matsukuma@morinomiya-u.ac.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
Hideaki Matsukuma
Funding Source
Organization
Morinomiya University of Medical Sciences
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
Morinomiya University of Medical Sciences
Address
1-26-16 Nankokita, Suminoe-ku, Osaka-shi, Osaka 559-8611, Japan
Tel
0666166911
matsukuma@morinomiya-u.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
森ノ宮医療大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 15 | 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
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 08 | Month | 18 | Day |
Last modified on
| 2026 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071665
