UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017892 |
|---|---|
| Receipt number | R000020729 |
| Scientific Title | The effectiveness of Maoto suppository for infants |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2015/06/12 18:45:36 |
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Basic information
Public title
The effectiveness of Maoto suppository for infants
Acronym
Effectiveness of Maoto suppository
Scientific Title
The effectiveness of Maoto suppository for infants
Scientific Title:Acronym
Effectiveness of Maoto suppository
Region
| Japan |
Condition
Condition
Cold
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We study the effectiveness of Maoto suppository for infants who have acute disease like fever.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
assess the fever period and improvement of the symptoms
Key secondary outcomes
Clinical findings (considering to age, gender, height, body weight,so on)
Laboratory findings (white blood cell, C-reactive protein)
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
Duration: 6 months
Quantity: 0.5 g
Time: once
The name of the drug: Tsumura Maoto Ekisu Karyu
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
| 1 | months-old | < |
Age-upper limit
| 72 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
the patients who come to our hospital whose age are under 6 years old.
the fever's duration should be under 3 days.
Key exclusion criteria
1) doctor can exclude the patients if they are not appropriate for this study
2) the patients who have underlying diseases like cardiac or kidney diseases
3) the patients who take other Kampo medicines before
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | watanabe toru |
Organization
Hamamatsu Rosai Hospital
Division name
Pediatrics
Zip code
Address
Hamamatsu City Higashi Distric Shogencho 25
TEL
053-462-1211
brightsirius@msn.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | watanabe toru |
Organization
Hamamatsu Rosai Hospital
Division name
Pediatrics
Zip code
Address
Hamamatsu City Higashi District Shogencho 25
TEL
053-462-1211
Homepage URL
http://www.hamamatsuh.rofuku.go.jp/
brightsirius@msn.com
Sponsor or person
Institute
Hamamatsu Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu Rosai Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2015 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.hamamatsuh.rofuku.go.jp/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.hamamatsuh.rofuku.go.jp/
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
Preinitiation
Date of protocol fixation
| 2015 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 12 | Day |
Last modified on
| 2015 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020729
| 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 |
