UMIN-CTR Clinical Trial

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
Email	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
Email	tetta213@keio.jp

Sponsor
Institute	Center for Kampo Medicine, Keio University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052503