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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007370
Receipt No. R000008678
Scientific Title The study of protective efficancy of postoprerative wound infection by Juzen-taiho-to after laryngo-tracheal separation
Date of disclosure of the study information 2012/02/23
Last modified on 2019/08/22

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Basic information
Public title The study of protective efficancy of postoprerative wound infection by Juzen-taiho-to after laryngo-tracheal separation
Acronym The protective efficancy of postoperative wound infection by Juzen-taiho-to
Scientific Title The study of protective efficancy of postoprerative wound infection by Juzen-taiho-to after laryngo-tracheal separation
Scientific Title:Acronym The protective efficancy of postoperative wound infection by Juzen-taiho-to
Region
Japan

Condition
Condition Dysfunction of larynx and pharynx
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study purpose is to determine whether Juzen-daiho-to administration can reduce post operative wound infection with laryngo-tracheal separation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes the sign of wound infection
Key secondary outcomes Laboratory findings(WBC, CRP)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Juzen-daiho-to
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients, who are performed to laryngo-tracheal separation, in our department
Key exclusion criteria 1) The patients of Juzen-daiho-to administration befor this study
2) The patients need preparation with licorice
3) The patients need preparation with glycyrrhizic acid
4)Liver dysfunction
5)The other reasons, which doctor judge inappropriate patient
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Komura
Organization The university of Tokyo Hosipital
Division name Departiment of Pediatric Surgery
Zip code
Address 7-3-1 Hongou Bunkyo-ku 113-8655 Tokyo Japan
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The university of Tokyo Hosipital
Division name Departiment of Pediatric Surgery
Zip code
Address
TEL
Homepage URL
Email crctky-office@umin.ac.jp

Sponsor
Institute Tokyo University
Pediatric Surgery
Institute
Department

Funding Source
Organization Tokyo University
Pediatric Surgery
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
Address
Tel
Email

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
2012 Year 02 Month 23 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 Terminated
Date of protocol fixation
2010 Year 06 Month 04 Day
Date of IRB
2010 Year 06 Month 04 Day
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2012 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 02 Month 23 Day
Last modified on
2019 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008678

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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