UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002871
Receipt number 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 20:50:40

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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