UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007370 |
|---|---|
| Receipt number | 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 18:03:40 |
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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
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
crctky-office@umin.ac.jp
Sponsor or person
Institute
Tokyo University
Pediatric Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008678
