UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031827 |
|---|---|
| Receipt number | R000036349 |
| Scientific Title | Reduction of wound swelling using herbal medicine, a combination of keishibukuryogan and jidabokuippo, in patients undergoing craniotomy: a randomized controlled trial |
| Date of disclosure of the study information | 2018/03/21 |
| Last modified on | 2019/03/24 17:05:34 |
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Basic information
Public title
Reduction of wound swelling using herbal medicine, a combination of keishibukuryogan and jidabokuippo, in patients undergoing craniotomy: a randomized controlled trial
Acronym
Reduction of wound swelling using herbal medicine in patients undergoing craniotomy
Scientific Title
Reduction of wound swelling using herbal medicine, a combination of keishibukuryogan and jidabokuippo, in patients undergoing craniotomy: a randomized controlled trial
Scientific Title:Acronym
Reduction of wound swelling using herbal medicine in patients undergoing craniotomy
Region
| Japan |
Condition
Condition
unruptured cerebral aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether herbal medicine, a combination of jidabokuippo and keishibukuryogan, reduces wound swelling in patients undergoing craniotomy for neck clipping of unruptured cerebral aneurysm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences of thickness of soft tissues on skull displayed on computed tomography performed before and after surgery (the 4th and 7th postoperative days)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with herbal medicine
1. Receiving keishibukuryogan (7.5g per day) from 2 days prior surgery to the day before surgery.
2. After confirming that consciousness and swallowing on the 1st postoperative day return to preoperative level, Receiving jidabokuippo (7.5g per day) in addition to keishibukuryogan.
Interventions/Control_2
Patients with herbal medicine
1. Not receiving herbal medicine
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
| 20 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Undergoing neck clipping through fronto-temporal craniotomy for unruptured cerebral aneurysm in our institute.
2)Age:74 or less and 20 or more.
3) Possible to administer jidabokuippo and keishibukuryogan.
4)Obtaining informed consent.
Key exclusion criteria
1)Expecting deterioration of symptoms such as liver function and Gastrointestinal disorders by administration of herbal medicine.
2)Presence of dysphagia.
3)Determining as "unsuitable for inclusion into this study" by an investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kuniaki |
| Middle name | |
| Last name | Ogasawara |
Organization
Iwate Medical University School of Medicine
Division name
Neurosurgery
Zip code
020-8505
Address
19-1 Uchimaru, Morioka, Japan
TEL
81-19-651-5111
kuogasa@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Koji |
Organization
Iwate Medical University School of Medicine
Division name
Neurosurgery
Zip code
020-8505
Address
19-1 Uchimaru, Morioka, Japan
TEL
81-19-651-5111
Homepage URL
thkoji@iwate-med.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Iwate Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Iwate Medical University School of Medicine
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
Iwate Medical University Hospital Ethics Committee
Address
19-1 Uchimaru, Morioka
Tel
81-19-651-5111
norimori@iwate-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
| 2018 | Year | 03 | Month | 21 | 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
| 2018 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 03 | Month | 21 | Day |
Last modified on
| 2019 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036349
| Research Plan | |
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| Registered date | File name |
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