UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027747 |
|---|---|
| Receipt number | 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 08:12:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hiroaki-matsu@umin.ac.jp
Sponsor or person
Institute
Cerebrovascular Research Institute, Eishokai Yoshida Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031753
