UMIN-CTR Clinical Trial

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
Last 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
Email	kuogasa@iwate-med.ac.jp

Public contact
1st 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
Email	thkoji@iwate-med.ac.jp

Sponsor
Institute	Department of Neurosurgery, Iwate Medical University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036349