UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010006 |
|---|---|
| Receipt number | R000011717 |
| Scientific Title | The effect of Goreisan to prevent the recurrence of chronic subdural hematoma |
| Date of disclosure of the study information | 2013/02/20 |
| Last modified on | 2021/08/24 07:28:27 |
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Basic information
Public title
The effect of Goreisan to prevent the recurrence of chronic subdural hematoma
Acronym
The effect of Goreisan to prevent the recurrence of chronic subdural hematoma
Scientific Title
The effect of Goreisan to prevent the recurrence of chronic subdural hematoma
Scientific Title:Acronym
The effect of Goreisan to prevent the recurrence of chronic subdural hematoma
Region
| Japan |
Condition
Condition
Chronic subdural hematoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic subdural hematoma (CSDH) is frequently seen among elderly population. With increased number of the advanced-aged, the incidence of CSDH is expected to rise. In general, simple surgical procedure such as one burr hole opening and irrigation of hematoma has been accepted as an effective method to treat symptomatic CSDH. However, the recurrence rate is not sufficiently low. Previous series have reported approximately 10% of cases recurred after surgical treatment. Recently, however, some pilot studies have shown the effectiveness of Goreisan, one of Chinese herbal medicines, to lower the incidence of postoperative recurrence of CSDH. Goreisan is thought to be involved in the alteration of osmotic pressure in the hematoma membrane.
The aim of this study is to confirm the effectiveness of Goreisan to prevent the CSDH recurrence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative symptomatic reaccumulation of hematoma.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1. Patients assigned to Goreisan group are started on Goreisan, 7.5g TID, for 3 months after surgery.
Interventions/Control_2
2. Patients assigned to No medicine group are simply followed-up on a out-patient basis.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with symptomatic chronic subdural hematoma who need surgical treatment
Key exclusion criteria
1. Patients under the age of 18
2. Patients already treated surgically before
3. Patients with possibilities to develop drug side effect
Target sample size
224
Research contact person
Name of lead principal investigator
| 1st name | Soichi |
| Middle name | |
| Last name | Oya |
Organization
Saitama Medical School/Center
Division name
Department of Neurosurgery
Zip code
350-8550
Address
Kamoda 1981, Kawagoe, Saitama, 350-1114, Japan
TEL
049-228-3671
sooya-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Naoaki |
| Middle name | |
| Last name | Fujisawa |
Organization
Saitama Medical School/Center
Division name
Department of Neurosurgery
Zip code
350-8550
Address
Kamoda 1981, Kawagoe, Saitama, 350-1114, Japan
TEL
049-228-3671
Homepage URL
naoaki@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical School
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Saitama Medical Center IRB
Address
Kamoda 1981, Kawagoe, Saitama, 350-8550, Japan
Tel
049-228-
smcrinri@saitama-med.ac.jp
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
| 2013 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/nmc/advpub/0/advpub_oa.2020-0287/_article/-char/ja/
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/nmc/advpub/0/advpub_oa.2020-0287/_article/-char/ja/
Number of participants that the trial has enrolled
224
Results
The present prospective randomized study did not prove the beneficial effect of adjuvant Goreisan treatment, although it approached significance to lower the recurrence rate in overall patients. However, it suggested the importance of selecting patients with high risk of recurrence. Based on our data, a subset of patients whose hematoma showed homogeneous and separated patterns on CT image might benefit from Goreisan treatment.
Results date posted
| 2021 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent initial surgery for symptomatic CSDH confirmed on computed tomography (CT) images were recruited in this study.
Participant flow
Written informed consent was obtained from all enrolled patients. Patients were instructed to continue Goreisan for at least 3 months unless they developed any side effect of Goreisan.
Adverse events
The occurrence of wound infection was not significant between the two groups (P = 0.57). No seizure was observed in Group G. Among three patients complaining of severe headache, diarrhea, and abdominal discomfort, one patient with headache was not able to tolerate and discontinued Goreisan treatment.
Outcome measures
The primary endpoint was the symptomatic recurrence of CSDH, and the secondary endpoint was the complications, including the adverse side effects of Goreisan.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2013 | Year | 02 | Month | 09 | Day |
Last modified on
| 2021 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011717
