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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002871
Receipt No. R000003505
Scientific Title Effects of Japanese herbal medicine Juzen-taiho-to in otitis-prone children
Date of disclosure of the study information 2009/12/12
Last modified on 2012/07/09

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Basic information
Public title Effects of Japanese herbal medicine Juzen-taiho-to in otitis-prone children
Acronym Effects of Japanese herbal medicine Juzen-taiho-to in otitis-prone children
Scientific Title Effects of Japanese herbal medicine Juzen-taiho-to in otitis-prone children
Scientific Title:Acronym Effects of Japanese herbal medicine Juzen-taiho-to in otitis-prone children
Region
Japan

Condition
Condition otitis-prone
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of JTT against intractable and recurrent infections in immature immune systems, we will administer JTT to otitis-prone infants and investigate clinical changes before and during JTT administration.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes frequency of acute otitis media
Key secondary outcomes antibiotics administration

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After obtaining informed consent, JTT at 0.10-0.14 g/kg per day was administered twice a day before milk or food for three months. No restrictions were imposed on conventional treatments for otitis media or any other disease while JTT was administered
Interventions/Control_2 Patients receive conventional treatments for otitis media for 3 months.
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
6 months-old <=
Age-upper limit
36 months-old >=
Gender Male and Female
Key inclusion criteria Children who had more than three episodes in six months, more than four episodes in one year.
Key exclusion criteria Patient with major complication
Patient who receives imuno-globlin or steroid
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshizaki Tomokazu
Organization Kanazawa university Graduate School of Medical Science
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code
Address 13-1 Takaramachi Kanazawa, Ishikawa
TEL 076-265-2413
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ito Makoto
Organization Kanazawa university Graduate School of Medical Science
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code
Address 13-1 Takaramachi Kanazawa, Ishikawa
TEL 076-265-2413
Homepage URL
Email makoto@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa university Graduate School of Medical Science Department of Otolaryngology, Head and Neck Surgery
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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 金沢大学病院(石川県)、旭川医科大学病院(北海道)、東北大学大学病院(宮城県)、・ 東京医科歯科大学病院(東京都)、・ 富山大学病院(富山県)、・ 和歌山県立医科大学病院(和歌山県)、・ 長崎大学病院(長崎県)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 12 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 Completed
Date of protocol fixation
2009 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 09 Month 01 Day
Date trial data considered complete
2011 Year 11 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 12 Month 10 Day
Last modified on
2012 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003505

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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