UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043244 |
|---|---|
| Receipt number | R000048950 |
| Scientific Title | Study for effects of the repetitive far-infrared irradiation on combining four points on the skin surface in immune system of healthy human subjects. |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2024/04/01 11:05:37 |
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Basic information
Public title
Study how the repetitive far-infrared irradiation on combining four points on the skin surface : 'Stress-Free therapy' affects human immune system.
Acronym
Effects of the repetitive far-infrared irradiation on combining four points on the skin surface on human immune system.
Scientific Title
Study for effects of the repetitive far-infrared irradiation on combining four points on the skin surface in immune system of healthy human subjects.
Scientific Title:Acronym
Effects of the repetitive far-infrared irradiation on combining four points on the skin surface in healthy human immune system.
Region
| Japan |
Condition
Condition
Healthy adults and adults in any conditions
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is intended to clarify how moderate infrared stimuli on specified human body surfaces modulate systemic immunological responses.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Effects on changes of peripheral blood lymphocyte compositions through a week and three weeks of long-wavelength infrared light irradiation or placebo irradiation.
Key secondary outcomes
Effects on changes of peripheral blood lymphocyte compositions of same subject groups by repetitive cycles of long-wavelength infrared light irradiation and placebo irradiation.
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Before treatments, 13 ml of peripheral blood (PB) will be collected for blood analyses. Aliquot 8 ml of PB will be applied for ZTT, Total bilirubin, AST, ALT, ALP, gamma-GTP, LAP, Uric acid, BUN, creatinine, eGFR, total cholesterol, HDL and LDL analyses. Other aliquot 5 ml will be applied for blood cell analyses. Then subject volunteers will be treated 2 days every week for 3 weeks by placebo irradiation as following, subjects resting in a spine or sitting position will be attached with irradiation probes of Stress Free Apparatus (authorization number for controlled medical device 224AFBZX00075000) for 15 minutes on 4 specified body surface points that are a (left side acupuncture point ST36, acupuncture point CV12 and both sides of tangent points between vertical line from malleolus medialis to planter and intermediate line between first and second metatarsal toes (hereafter these points named F-points). On the 7th day and the last day of placebo irradiations, 13 ml of PB will be collected from respective subject and will be applied for blood analyses as stated above. Consequently, subject volunteers will be treated 2 days every week for 3 weeks by infrared irradiation as following, subjects resting in a spine or sitting position will be irradiated by infrared pulse laser (wavelength 9,000 - 12,000 nm, maximum output level 2,700 J for 30 seconds with 1 minute interval) 15 minutes on 4 specified body surface points as stated above. On the 7th day and the last day of infrared irradiations, 13 ml of PB will be collected from respective subject and will be applied for blood analyses as stated above. These treatments i.e. placebo irradiations and infrared irradiations will be repeated alternately two times and blood tests will be done as stated above. Additional blood test will also be done on the day a week after the end of treatments.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Adults over 20 years old
2. Volunteers signed agreement to be subjects of this study after informed consent.
3. People who has not been treated with pinpoint plantar long-wavelength infrared light irradiation therapy, acupuncture, moxibustion and/or thermal therapies more than 1 month.
Key exclusion criteria
People who were judged as not suitable as subjects for the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Nakajima |
Organization
SBC Tokyo Medical University
Division name
Center for Medical Education, Faculty of Health Sciences
Zip code
279-8567
Address
5-8-1, Akemi, Urayasu-city, Chiba Prefecture
TEL
047-382-2485
t-nakajima@sbctmu.ac.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Nakajima |
Organization
SBC Tokyo Medical University
Division name
Center for Medical Education, Faculty of Health Sciences
Zip code
279-8567
Address
5-8-1, Akemi, Urayasu-city, Chiba Prefecture
TEL
047-382-2485
Homepage URL
t-nakajima@sbctmu.ac.jp
Sponsor or person
Institute
SBC Tokyo Medical University,
Center for Medical Education, Faculty for Health Sciences
Institute
Department
Personal name
Funding Source
Organization
SBC Tokyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB and ethics committee for SBC Tokyo Medical University
Address
5-8-1, Akemi, Urayasu-city, Chiba Prefecture
Tel
047-382-2111
dan@sbctmu.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
SBC東京医療大学（千葉県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
28
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
| 2014 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2021 | 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
| 2021 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048950
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