UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023090 |
|---|---|
| Receipt number | R000026610 |
| Scientific Title | A single-institutional study for the efficacy and optimal dose and method of Japanese herbal medicine in pediatric patients |
| Date of disclosure of the study information | 2016/07/11 |
| Last modified on | 2017/07/10 11:28:23 |
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Basic information
Public title
A single-institutional study for the efficacy and optimal dose and method of Japanese herbal medicine in pediatric patients
Acronym
A single-institutional study of Japanese herbal medicine in pediatric patients
Scientific Title
A single-institutional study for the efficacy and optimal dose and method of Japanese herbal medicine in pediatric patients
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kohei Otake |
Organization
Mie University Graduate School of Medicine
Division name
Department of Gastrointestinal and Pediatric Surgery
Zip code
Address
Edobashi 2-174, Tsu, Mie 514-8507, JAPAN
TEL
059-232-1111(5645)
kohei815@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohei Otake |
Organization
Mie University Graduate School of Medicine
Division name
Department of Gastrointestinal and Pediatric Surgery
Zip code
Address
Edobashi 2-174, Tsu, Mie 514-8507, JAPAN
TEL
059-232-1111(5645)
Homepage URL
kohei815@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
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)
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
| 2016 | Year | 07 | Month | 11 | 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
The lead principal investigator moved to another hospital in April 2017. Thus, this study was impossible to continue in the Mie university hospital.
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
| 2016 | Year | 04 | Month | 21 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026610
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
