UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004455 |
|---|---|
| Receipt number | R000005333 |
| Scientific Title | The study to verify the safety and effects of SHIRSAKU therapy |
| Date of disclosure of the study information | 2010/10/27 |
| Last modified on | 2010/10/27 12:17:04 |
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Basic information
Public title
The study to verify the safety and effects of SHIRSAKU therapy
Acronym
SHIRAKU thrapy study
Scientific Title
The study to verify the safety and effects of SHIRSAKU therapy
Scientific Title:Acronym
SHIRAKU thrapy study
Region
| Japan |
Condition
Condition
Chronic health disorder
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety and effects of SHIRAKU therapy,we study SAIRAKU from a morphological point of view. 1.SAIRAKU is a small superficious anastomosis of the vessels which we can see the skin. 2.Traditionally bloodletting from the SAIRAKU is useful for the patients who has chronic health disoerders.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To patternize the morphological information of SAIRAKU in patients
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who are agree to be observed their SAIRAKU.
Key exclusion criteria
The patients who don't want.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Denichiro Yamaoka |
Organization
Ehime Prefectural Central Hospital
Division name
Oriental medical institute
Zip code
Address
83 kasuga-machi matuyama-shi ehime-ken
TEL
089-947-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoko Otsuka |
Organization
Ehime Prefectural Central Hospital
Division name
Oriental medical institute
Zip code
Address
83 kasuga-machi matuyama-shi ehime-ken
TEL
089-947-1111
Homepage URL
c-motsuka@eph.pref.ehime.jp
Sponsor or person
Institute
Oriental medical institute of Ehime Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
SHIRAKU association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
愛媛県立中央病院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 27 | 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
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
Preinitiation
Date of protocol fixation
| 2010 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
There is no report about shiraku therapy.
Our classification is the first model of them.
Management information
Registered date
| 2010 | Year | 10 | Month | 27 | Day |
Last modified on
| 2010 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005333
