UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041922 |
|---|---|
| Receipt number | R000047844 |
| Scientific Title | Studies on the incidence rate of subcutaneous hemorrhages after the cosmetic acupuncture treatment |
| Date of disclosure of the study information | 2020/09/28 |
| Last modified on | 2021/09/30 12:04:18 |
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Basic information
Public title
Studies on the incidence rate of subcutaneous hemorrhages after the cosmetic acupuncture treatment
Acronym
Research on cosmetic acupuncture
Scientific Title
Studies on the incidence rate of subcutaneous hemorrhages after the cosmetic acupuncture treatment
Scientific Title:Acronym
Research on cosmetic acupuncture
Region
| Japan |
Condition
Condition
Healthy woman
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the incident rate of subcutaneous hemorrhages after cosmetic acupuncture within a clinical setting. Additionally, we will analyze contributing factors, such as treatment conditions and technica differences
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of subcutaneous hemorrhages
Key secondary outcomes
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
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Cosmetic Acupuncture Treatment
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
| Not applicable |
Gender
Female
Key inclusion criteria
The plans woman who undergo a cosmetic Acupuncture Treatment
Key exclusion criteria
Exclusion target under the age of 20years old.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | KOZUE |
| Middle name | |
| Last name | ORIHASHI |
Organization
All japan cosmetic acupuncture federation
Division name
Academic faculty
Zip code
106-0045
Address
#301 monte plaza 1-10-3 azabujyuban minato-ku tokyo
TEL
03-6277-6838
info@ajcaf.or.jp
Public contact
Name of contact person
| 1st name | KOZUE |
| Middle name | |
| Last name | ORIHASHI |
Organization
Bishinkai
Division name
Academic faculty
Zip code
108-0071
Address
#403 trentedeux 5-2-5 shirokane minato-ku tokyo
TEL
03-6450-3623
Homepage URL
contact@bishinkai.com
Sponsor or person
Institute
All japan cosmetic acupuncture federation
Institute
Department
Personal name
Funding Source
Organization
All japan cosmetic acupuncture federation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
All japan cosmetic acupuncture federation Ethics review committee Secretariat : Co. remedia
Address
F6 kisukeshinkanda-building 10 kandamikura-cho chiyoda-ku tokyo
Tel
03-3525-8455
t-koshiba@remedia-cro.com
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 28 | 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
602
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
Main results already published
Date of protocol fixation
| 2020 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2020 | Year | 09 | Month | 28 | Day |
Last modified on
| 2021 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047844
