UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009977
Receipt No. R000011687
Scientific Title Effects of Juzen-taiho-to in infantile perianal abscess: a multiple center randomized controlled study
Date of disclosure of the study information 2013/02/06
Last modified on 2013/02/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of Juzen-taiho-to in infantile perianal abscess: a multiple center randomized controlled study
Acronym Effects of Juzen-taiho-to in infantile perianal abscess: a multiple center randomized controlled study
Scientific Title Effects of Juzen-taiho-to in infantile perianal abscess: a multiple center randomized controlled study
Scientific Title:Acronym Effects of Juzen-taiho-to in infantile perianal abscess: a multiple center randomized controlled study
Region
Japan

Condition
Condition Perianal abscess
Classification by specialty
Surgery in general Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of Juzen-taiho-to in infantile perianal abscess
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes recurrence
Key secondary outcomes Period required for complete healing, rate of surgical procedure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Juzen-taiho-to (Tsumura)
Interventions/Control_2 probiotics
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
1 years-old >
Gender Male
Key inclusion criteria 1) informed consent from the guardian
2) outpatient
Key exclusion criteria 1) complication of severe underlying disease
2) premature infant
3) complication of immunodeficiency or suspected
4) post-operated
5) necessity of antibiotics for other illness
6) necessity of Kampo medicine for other illness
7) refractory diarrhea
8) malnourished
9) treated at other institution
Target sample size 125

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo Yoshida
Organization Chiba University School of Medicine
Division name Department of Pediatric Surgery
Zip code
Address 1-8-1 Inohana, Chuoku, Chiba City 260-8677 Japan
TEL 043-226-2312
Email

Public contact
Name of contact person
1st name
Middle name
Last name Elena Terui
Organization Chiba University School of Medicine
Division name Department of Pediatric Surgery
Zip code
Address 1-8-1 Inohana, Chuoku, Chiba City 260-8677 Japan
TEL 043-226-2312
Homepage URL
Email elenan@cc.rim.or.jp

Sponsor
Institute Chiba University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Matsudo City Hospital Children's Medical Center, Kimitsu Chuo Hospital
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 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 06 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
2012 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 06 Day
Last modified on
2013 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011687

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.