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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004455
Receipt No. 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

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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
Last 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
Email

Public contact
1st 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
Email c-motsuka@eph.pref.ehime.jp

Sponsor
Institute Oriental medical institute of Ehime Prefectural Central Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005333

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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