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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031827
Receipt No. 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

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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
Email 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
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/ctr_e/ctr_view.cgi?recptno=R000036349

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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