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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027747
Receipt No. R000031753
Scientific Title The effect of Kampo medicine for prevention of chronic subdural hematoma recurrence-prosepective study
Date of disclosure of the study information 2017/06/19
Last modified on 2017/06/14

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Basic information
Public title The effect of Kampo medicine for prevention of chronic subdural hematoma recurrence-prosepective study
Acronym The effect of Kampo medicine for prevention of chronic subdural hematoma recurrence-prosepective study
Scientific Title The effect of Kampo medicine for prevention of chronic subdural hematoma recurrence-prosepective study
Scientific Title:Acronym The effect of Kampo medicine for prevention of chronic subdural hematoma recurrence-prosepective study
Region
Japan

Condition
Condition chronic subdural hematoma
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The object is to investigate whether Kampo medicine (goreisan or saireito) prevent from postoperative recurrence of chronic subdural hematoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recurrence required operation
Key secondary outcomes Side effect

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of goreisan
Interventions/Control_2 Administration of saireito
Interventions/Control_3 No administration of Kampo medicine
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 Male and Female
Key inclusion criteria 1.Patient aged 20 and over
2.Patinet diagnosed as primary chronic subdural hematoma and performed the operation of drainage
3.Patinent with self-sufficient
Key exclusion criteria 1.Patient with severe dementia
2.Patient unable to take Kampo medicine
3.Bedridden patient
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Matsumoto
Organization Cerebrovascular Research Institute, Eishokai Yoshida Hospital
Division name Department of Neurosurgery
Zip code
Address Daikai-dori9-2-6, Hyogo-ku, Kobe 652-0803, Japan
TEL 078-576-2773
Email hiroaki-matsu@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Matsumoto
Organization Cerebrovascular Research Institute, Eishokai Yoshida Hospital
Division name Department of Neurosurgery
Zip code
Address Daikai-dori9-2-6, Hyogo-ku, Kobe 652-0803, Japan
TEL 078-576-2773
Homepage URL
Email hiroaki-matsu@umin.ac.jp

Sponsor
Institute Cerebrovascular Research Institute, Eishokai Yoshida Hospital
Institute
Department

Funding Source
Organization n/a
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

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 19 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 14 Day
Last modified on
2017 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031753

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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