UMIN-CTR Clinical Trial

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
Email	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
Email	naoaki@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical School
Institute
Department

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-
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011717