UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007443 |
|---|---|
| Receipt number | R000008773 |
| Scientific Title | Management of perianal abscess with hainosankyuto infants: Multiple center trial |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2015/09/07 06:04:47 |
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Basic information
Public title
Management of perianal abscess with hainosankyuto infants: Multiple center trial
Acronym
Prospective study
Scientific Title
Management of perianal abscess with hainosankyuto infants: Multiple center trial
Scientific Title:Acronym
Prospective study
Region
| Japan |
Condition
Condition
perianal abscess
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of hainosankyuto for perianal abscess
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
local condition
Key secondary outcomes
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
hainosankyuto
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
| 0 | years-old | <= |
Age-upper limit
| 1 | years-old | > |
Gender
Male and Female
Key inclusion criteria
infant with perianal abscess
Key exclusion criteria
impossible of administration
not effective within 1 week
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiminobu Sugito |
Organization
Nihon University School of Medicine, Itabashi Hospital
Division name
Pediatric surgery
Zip code
Address
30-1, Ohyaguchi Kamicho, Itabashiku, Tokyo, Japan
TEL
03-3972-8111
sugitou.kiminobu@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiminobu Sugito |
Organization
Nihon University, School of Medicine
Division name
Pediatric Surgery
Zip code
Address
30-1, Ohyaguchi Kamicho, Itabashiku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
sugitou.kiminobu@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon 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
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 | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 05 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 05 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 05 | Day |
Last modified on
| 2015 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008773
