UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A single-institutional study for the efficacy and optimal dose and method of Japanese herbal medicine in pediatric patients
Title of the study (Brief title)	A single-institutional study of Japanese herbal medicine in pediatric patients
Region	Japan

Condition
Condition	Pediatric diseases
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of Japanese herbal medicine in pediatric patients
Basic objectives2	Others
Basic objectives -Others	Efficacy, safety, medication adherence, optimal method, and consciousness survey
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Efficacy
Key secondary outcomes	Safety, medication adherence, optimal method, consciousness, and survey

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old >=
Gender	Male and Female
Key inclusion criteria	1. All patients with pediatric surgical disease, visiting our outpatient clinic or hospitalized in our institute. 2. All patients are required to give written informed consent prior to enrolment in the study. 3. Patients who are under 10 years old are required to give written informed consent from proxy. 4. Patients who are aged over 10 years and below 20 years are required to give written informed assent and written informed consent from proxy.
Key exclusion criteria	1. Known allergy or contraindication to Japanese herbal medicine 2.Patients whom investigators consider to be ineligible
Target sample size	700

Research contact person
Name of lead principal investigator	Kohei Otake
Organization	Mie University Graduate School of Medicine
Division name	Department of Gastrointestinal and Pediatric Surgery
Address	Edobashi 2-174, Tsu, Mie 514-8507, JAPAN
TEL	059-232-1111(5645)
Email	kohei815@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Kohei Otake
Organization	Mie University Graduate School of Medicine
Division name	Department of Gastrointestinal and Pediatric Surgery
Address	Edobashi 2-174, Tsu, Mie 514-8507, JAPAN
TEL	059-232-1111(5645)
Homepage URL
Email	kohei815@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 07 Month 11 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 04 Month 21 Day
Anticipated trial start date	2016 Year 07 Month 11 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	The lead principal investigator moved to another hospital in April 2017. Thus, this study was impossible to continue in the Mie university hospital.
Other related information	Prospective and retrospective observational study

Management information
Registered date	2016 Year 07 Month 09 Day
Last modified on	2017 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026610