UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049678
Receipt number R000055395
Scientific Title Establishment of objective beauty evaluation method by acupuncture stimulation based on image anatomy
Date of disclosure of the study information 2022/12/02
Last modified on 2023/12/04 10:01:08

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Basic information

Public title

Establishment of objective beauty evaluation method by acupuncture stimulation based on image anatomy

Acronym

Establishment of objective beauty evaluation method by acupuncture stimulation based on image anatomy

Scientific Title

Establishment of objective beauty evaluation method by acupuncture stimulation based on image anatomy

Scientific Title:Acronym

Establishment of objective beauty evaluation method by acupuncture stimulation based on image anatomy

Region

Japan


Condition

Condition

Beauty acupuncture

Classification by specialty

Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Analysis of changes in facial subcutaneous structures induceced by acupuncuture stimulation using by MRI

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Perform acupuncuture stimulation once a week for atotal of 8times,and perform MRI imaging before and 8times after acupuncuture stimulation to
evaluation changes in facial subcutaneous

Key secondary outcomes

Photo evaluation
Evaluation by survey


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Perform period from December,2022,10subjects will receive beauty acupuncture once a week ,a total 8times ,using 30 mm stainless steel acupuncture needles manufactured by seirin

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

40 years-old <=

Age-upper limit

60 years-old >

Gender

Female

Key inclusion criteria

Heaithy adult female

Key exclusion criteria

with metal inside
Subjects with facial nerve palsy or trauma to the face
claustrophobic
subjects with a tattoo
subjects who recieve cosmetic surgery during the study period

Target sample size

10


Research contact person

Name of lead principal investigator

1st name ITSUKO
Middle name
Last name OKUDA

Organization

SUZUKA UNIVERSITY OF MEDICAL SCIENCE

Division name

Health science

Zip code

5100293

Address

1001-1 Kishiokachou,Suzuka,Mie

TEL

059-383-8991

Email

okudai812@gmail.com


Public contact

Name of contact person

1st name MIEKO
Middle name
Last name OGINO

Organization

Kou acupuncuture clinic

Division name

acupuncture

Zip code

1600022

Address

313 Rune gyoen plaza 1-24-7 Shinjuku-ku, Shinjuku, Tokyo

TEL

0333586402

Homepage URL


Email

info@kouhari.com


Sponsor or person

Institute

Kou acupuncuture clinic

Institute

Department

Personal name



Funding Source

Organization

Kou acupuncuture clinic

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

SUZUKA UNIVERSITY OF MEDICAL SCIENCE

Address

3500-3 Minamitamagakichou,Suzuka,Mie

Tel

059-373-7811

Email

mayumi@suzuka-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

506

Org. issuing International ID_1

506

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

コウ鍼灸治療院


Other administrative information

Date of disclosure of the study information

2022 Year 12 Month 02 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

10

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

2022 Year 11 Month 25 Day

Date of IRB

2022 Year 11 Month 25 Day

Anticipated trial start date

2022 Year 11 Month 25 Day

Last follow-up date

2027 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

2022 Year 12 Month 02 Day

Last modified on

2023 Year 12 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055395


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name