UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061828 |
|---|---|
| Receipt number | R000070729 |
| Scientific Title | Reserch to visualize the health promoting effects of chiropractic intervention using health indicators |
| Date of disclosure of the study information | 2026/06/08 |
| Last modified on | 2026/06/08 16:38:56 |
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Basic information
Public title
Research to visualize the health promoting effects of chiropractic treatment
Acronym
Research to Visualize the Health Promoting Effects of Chiropractic Treatment
Scientific Title
Reserch to visualize the health promoting effects of chiropractic intervention using health indicators
Scientific Title:Acronym
Research to Visualize the Health Promoting Effects of Chiropractic Treatment Using Health Indicators
Region
| Japan |
Condition
Condition
Not applicable (Healthy adult)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study focuses particularly on immunity, which is deeply involved in health promotion, and comprehensively evaluates QOL (SF-36) before and after chiropractic intervention, along with saliva-derived biomarkers (IgA, cortisol, Beta-defensin, CRP) and body temperature, to non-invasively and quantitatively analyze the health-promoting effects of chiropractic treatment. This aims to visualize the health-promoting effects of simple and practical chiropractic intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Salivary biomarker (secretory IgA)
Key secondary outcomes
Salivary biomarkers (cortisol, Beta-defensin (hBD-2), CRP), SF-36 (QOL summary score), body temperature, immune barrier monitoring results
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A group receiving chiropractic treatment once a week for eight consecutive weeks (each session lasting approximately 40 minutes, with a low intensity).
Interventions/Control_2
A group receiving chiropractic treatment once a week for eight consecutive weeks (each session lasting approximately 40 minutes, with a high intensity).
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who have received a thorough explanation of the research's purpose and content, fully understood it, and voluntarily volunteered to participate and agreed to participate in the research.
Key exclusion criteria
1) Individuals with a serious underlying medical condition
2) Individuals undergoing immunosuppressive therapy
3) Pregnant individuals
4) Individuals experiencing oral symptoms accompanied by bleeding, such as bleeding gums
5) Individuals who are scheduled to receive the same chiropractic treatment within two weeks prior to the start of the study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Tsuji |
Organization
iFoodMed inc.
Division name
Research and Development Department
Zip code
300-0873
Address
161-11 Arakawaoki, Tsuchiura City, Ibaraki Prefecture
TEL
080-6595-2420
tsuji.noriko@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Unno |
Organization
Factory Japan Group Co., LTD
Division name
External Affairs and Public Relations Office
Zip code
101-0041
Address
5F, Kanda Sudacho Place, 1-9 Kanda Sudacho, Chiyoda-ku, Tokyo
TEL
080-6568-4188
Homepage URL
y.unno@factoryjapan.co.jp
Sponsor or person
Institute
iFoodMed inc.
Institute
Department
Personal name
Funding Source
Organization
NEC Solution Innovators, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
CPCC Company Limited
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic.
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo
Tel
03-6225-9005
IRB@cpcc.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
CMK26C1
Org. issuing International ID_1
Institutional Review Board of Chiyoda Paramedical Care Clinic.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 08 | 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
65
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 09 | 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 | 06 | Month | 08 | Day |
Last modified on
| 2026 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070729
