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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017892
Receipt No. 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

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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
Email 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/
Email brightsirius@msn.com

Sponsor
Institute Hamamatsu Rosai Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020729

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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