UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000042776
Receipt number	R000048660
Scientific Title	Analyses of peripheral blood and immune cells for systemic effects of the repetitive far-infrared irradiation on combining four points on the skin surface.
Date of disclosure of the study information	2022/04/01
Last modified on	2024/08/02 15:33:58

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Basic information

Public title

Analyses of the peripheral blood serum and immune cells for systemic effects of repetitive far-infrared irradiation on combining four points on the skin surface : 'Stress-Free therapy'

Acronym

Analyses for systemic effects of the repetitive far-infrared irradiation on combining four points on the skin surface

Scientific Title

Analyses of peripheral blood and immune cells for systemic effects of the repetitive far-infrared irradiation on combining four points on the skin surface.

Scientific Title:Acronym

Analyses for systemic effects of the repetitive far-infrared irradiation on combining four points on the skin surface.

Region

Japan

Condition

Healthy adults and adults in any conditions

Classification by specialty

Medicine in general Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

This study is intended to clarify how moderate infrared stimuli on specified human body surfaces modulate systemic immunological and endocrinal 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 after 3 weeks and/or 8 weeks of stimuli.

Key secondary outcomes

1. Effect on changes of hormone balances in peripheral blood after 3 weeks and/or 8 weeks of stimuli.
2. Effect on changes of blood cholesterols and fat values after 3 weeks and/or 8 weeks of stimuli.

Base

Study type

Interventional

Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Before treatments, 15 ml of peripheral blood (PB) will be collected for blood analyses. Aliquot 8 ml of PB will be applied for cortisol, growth hormone, somatomedin C, AST, ALT, ALP, LAP, gamma-GTP, total cholesterol, HDL, LDL, UA, CRP, RF, Estrogen E2 and Prolactin analyses. Other aliquot 2 ml of PB will be applied for blood sugar and HbA1c analyses and remaining aliquot 5 ml will be applied for blood cell analyses. Then subject volunteers will be treated at least 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 II (authorization number for controlled medical device 227AFBZX00066000) for 45 minutes on 4 specified body surface points that are a left side acupuncture point ST36, an intermediate point between left side acupuncture points ST3 and ST4 (hereafter this point is named as left side N-point), an intermediate point between upper edge of right side margo supraorbitalisia and right side acupuncture point GB4 (hereafter this point named right side L-point), and a tangent point between vertical line from left malleolus medialis to planter and intermediate line between first and second metatarsal toes (hereafter this point named left side F-point). On the last day of placebo irradiations, 15 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 at least 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) 45 minutes on 4 specified body surface points as stated above. On the last day of treatments, 15 ml of PB will be collected from respective subject and will be applied for blood analyses as stated above.

Interventions/Control_2

Before treatments, 15 ml of PB will be collected for blood analyses. Aliquot 8 ml of PB will be applied for cortisol, growth hormone, somatomedin C, AST, ALT, ALP, LAP, gamma-GTP, total cholesterol, HDL, LDL, UA, CRP, RF, Estrogen E2 and Prolactin analyses. Other aliquot 2 ml of PB will be applied for blood sugar and HbA1c analyses and remaining aliquot 5 ml will be applied for blood cell analyses. Then subject volunteers will be treated at least 2 days every week for 8 weeks by placebo irradiation as following, subjects resting in a spine or sitting position will be attached with irradiation probes of Stress Free Apparatus II for 45 minutes on 4 specified body surface points (left side acupuncture point ST36, left side N-point, right side L-point and left side F-point). On the last day of placebo irradiations, 15 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 at least 2 days every week for 8 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) 45 minutes on 4 specified body surface points as stated above. On the last day of treatments, 15 ml of PB will be collected from respective subject and will be applied for blood analyses as stated above.

Interventions/Control_3

Before treatments, 15 ml of PB will be collected for blood analyses. Aliquot 8 ml of PB will be applied for cortisol, growth hormone, somatomedin C, AST, ALT, ALP, LAP, gamma-GTP, total cholesterol, HDL, LDL, UA, CRP, RF, Estrogen E2 and Prolactin analyses. Other aliquot 2 ml of PB will be applied for blood sugar and HbA1c analyses and remaining 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 II for 45 minutes on 4 specified body surface points (left side acupuncture point ST36, acupuncture point CV12 and both sides F-points). On the last day of placebo irradiations, 15 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 at least 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) 45 minutes on 4 specified body surface points as stated above. On the last day of treatments, 15 ml of PB will be collected from respective subject and will be applied for blood analyses as stated above.

Interventions/Control_4

Before treatments, 15 ml of PB will be collected for blood analyses. Aliquot 8 ml of PB will be applied for cortisol, growth hormone, somatomedin C, AST, ALT, ALP, LAP, gamma-GTP, total cholesterol, HDL, LDL, UA, CRP, RF, Estrogen E2 and Prolactin analyses. Other aliquot 2 ml of PB will be applied for blood sugar and HbA1c analyses and remaining aliquot 5 ml will be applied for blood cell analyses. Then subject volunteers will be treated at least 2 days every week for 8 weeks by placebo irradiation as following, subjects resting in a spine or sitting position will be attached with irradiation probes of Stress Free Apparatus II for 45 minutes on 4 specified body surface points (left side acupuncture point ST36, acupuncture point CV12 and both sides F-points). On the last day of placebo irradiations, 15 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 at least 2 days every week for 8 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) 45 minutes on 4 specified body surface points as stated above. On the last day of treatments, 15 ml of PB will be collected from respective subject and will be applied for blood analyses as stated above.

Interventions/Control_5

Before treatments, 15 ml of PB will be collected for blood analyses. Aliquot 8 ml of PB will be applied for cortisol, growth hormone, somatomedin C, AST, ALT, ALP, LAP, gamma-GTP, total cholesterol, HDL, LDL, UA, CRP, RF, Estrogen E2 and Prolactin analyses. Other aliquot 2 ml of PB will be applied for blood sugar and HbA1c analyses and remaining aliquot 5 ml will be applied for blood cell analyses. Then subject volunteers will be treated at least 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 II for 45 minutes on 4 specified body surface points (left side acupuncture point ST36, left side N-point, right side P-point (center point of right-side eyelid) and left side F-point). On the last day of placebo irradiations, 15 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 at least 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) 45 minutes on 4 specified body surface points as stated above. On the last day of treatments, 15 ml of PB will be collected from respective subject and will be applied for blood analyses as stated above.

Interventions/Control_6

Before treatments, 15 ml of PB will be collected for blood analyses. Aliquot 8 ml of PB will be applied for cortisol, growth hormone, somatomedin C, AST, ALT, ALP, LAP, gamma-GTP, total cholesterol, HDL, LDL, UA, CRP, RF, Estrogen E2 and Prolactin analyses. Other aliquot 2 ml of PB will be applied for blood sugar and HbA1c analyses and remaining aliquot 5 ml will be applied for blood cell analyses. Then subject volunteers will be treated at least 2 days every week for 8 weeks by placebo irradiation as following, subjects resting in a spine or sitting position will be attached with irradiation probes of Stress Free Apparatus II for 45 minutes on 4 specified body surface points (left side acupuncture point ST36, left side N-point, right side P-point and left side F-point). On the last day of placebo irradiations, 15 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 at least 2 days every week for 8 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) 45 minutes on 4 specified body surface points as stated above. On the last day of treatments, 15 ml of PB will be collected from respective subject and will be applied for blood analyses as stated above.

Interventions/Control_7

Before treatments, 15 ml of PB will be collected for blood analyses. Aliquot 8 ml of PB will be applied for cortisol, growth hormone, somatomedin C, AST, ALT, ALP, LAP, gamma-GTP, total cholesterol, HDL, LDL, UA, CRP, RF, Estrogen E2 and Prolactin analyses. Other aliquot 2 ml of PB will be applied for blood sugar and HbA1c analyses and remaining aliquot 5 ml will be applied for blood cell analyses. Then subject volunteers will be treated at least 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 II for 45 minutes on 4 specified body surface points (left side acupuncture point ST36, left side N-point and both side F-points). On the last day of placebo irradiations, 15 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 at least 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) 45 minutes on 4 specified body surface points as stated above. On the last day of treatments, 15 ml of PB will be collected from respective subject and will be applied for blood analyses as stated above.

Interventions/Control_8

Before treatments, 15 ml of PB will be collected for blood analyses. Aliquot 8 ml of PB will be applied for cortisol, growth hormone, somatomedin C, AST, ALT, ALP, LAP, gamma-GTP, total cholesterol, HDL, LDL, UA, CRP, RF, Estrogen E2 and Prolactin analyses. Other aliquot 2 ml of PB will be applied for blood sugar and HbA1c analyses and remaining aliquot 5 ml will be applied for blood cell analyses. Then subject volunteers will be treated at least 2 days every week for 8 weeks by placebo irradiation as following, subjects resting in a spine or sitting position will be attached with irradiation probes of Stress Free Apparatus II for 45 minutes on 4 specified body surface points (left side acupuncture point ST36, left side N-point and both side F-points). On the last day of placebo irradiations, 15 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 at least 2 days every week for 8 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) 45 minutes on 4 specified body surface points as stated above. On the last day of treatments, 15 ml of PB will be collected from respective subject and will be applied for blood analyses as stated above.

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

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

Email

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

Email

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

Email

dan@sbctmu.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

SBC東京医療大学（千葉県）

Other administrative information

Date of disclosure of the study information

2022 Year 04 Month 01 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

Open public recruiting

Date of protocol fixation

2020 Year 09 Month 27 Day

Date of IRB

2020 Year 10 Month 28 Day

Anticipated trial start date

2020 Year 11 Month 09 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry

2025 Year 10 Month 31 Day

Date trial data considered complete

2025 Year 10 Month 31 Day

Date analysis concluded

2026 Year 08 Month 31 Day

Other

Other related information

Because of Covid-19 pandemic, the recruitment of subjects has not advanced. So the term of clinical experiment has been extended to the end of March 2023.
Study period had been extended on March 31th, 2023 for lack of subjects.
On March 31th, 2024, study period has been re-extended again for lack of subjects.

Management information

Registered date

2020 Year 12 Month 17 Day

Last modified on

2024 Year 08 Month 02 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048660