UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046019 |
|---|---|
| Receipt number | R000052503 |
| Scientific Title | Verification of new parameters for establishing a new clinical research model for acupuncture and moxibustion |
| Date of disclosure of the study information | 2021/11/15 |
| Last modified on | 2022/05/11 09:49:17 |
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Basic information
Public title
The observational study with effect of acupuncture and moxibustion
Acronym
The observational study with effect of acupuncture and moxibustion
Scientific Title
Verification of new parameters for establishing a new clinical research model for acupuncture and moxibustion
Scientific Title:Acronym
Verification of new parameters for establishing a new clinical research model for acupuncture and moxibustion
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to construct a quantifiable parameter for the acupuncture and moxibustion therapy
Basic objectives2
Others
Basic objectives -Others
Verify whether contour information on the body surface reflects the effects of acupuncture and moxibustion treatment
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
3D image technology
Before and after the acupuncture and moxibustion therapy
Key secondary outcomes
Thermograph
Before and after the acupuncture and moxibustion therapy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who can rest for about 30 minutes in the prone position
2) Research subjects visiting the acupuncture and moxibustion outpatient of our Kampo Medical Center
3) Research subjects with written consent
Key exclusion criteria
1) Persons with diseases such as scoliosis with large height difference on the back
2) Those who have a large laterality on the back due to surgical scars, etc.
3) Persons with large scratches or bruises on the back that may cause errors in image capture
4)Those who are deemed inappropriate for conducting this research by the investigator or the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Mimura |
Organization
Keio University
Division name
Keio University School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3879
mimura@a7.keio.jp
Public contact
Name of contact person
| 1st name | TETSUHIRO |
| Middle name | |
| Last name | YOSHINO |
Organization
Keio University
Division name
Center for Kampo Medicine, Keio University School of Medicin
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5366-3824
Homepage URL
tetta213@keio.jp
Sponsor or person
Institute
Center for Kampo Medicine, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board of Keio
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
慶應義塾大学病院漢方医学センター/ Center for Kampo Medicine, Keio University School of Medicine
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.keio-kampo.jp/ja_2/page07.html
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
| 2021 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 31 | Day |
Other
Other related information
Recruitment period:
From November 10, 2021 to March 31, 2022
Management information
Registered date
| 2021 | Year | 11 | Month | 09 | Day |
Last modified on
| 2022 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052503
