Unique ID issued by UMIN | UMIN000002871 |
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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 |
Effects of Japanese herbal medicine Juzen-taiho-to in otitis-prone children
Effects of Japanese herbal medicine Juzen-taiho-to in otitis-prone children
Effects of Japanese herbal medicine Juzen-taiho-to in otitis-prone children
Effects of Japanese herbal medicine Juzen-taiho-to in otitis-prone children
Japan |
otitis-prone
Oto-rhino-laryngology |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Phase III
frequency of acute otitis media
antibiotics administration
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Medicine |
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
Patients receive conventional treatments for otitis media for 3 months.
6 | months-old | <= |
36 | months-old | >= |
Male and Female
Children who had more than three episodes in six months, more than four episodes in one year.
Patient with major complication
Patient who receives imuno-globlin or steroid
100
1st name | |
Middle name | |
Last name | Yoshizaki Tomokazu |
Kanazawa university Graduate School of Medical Science
Department of Otolaryngology, Head and Neck Surgery
13-1 Takaramachi Kanazawa, Ishikawa
076-265-2413
1st name | |
Middle name | |
Last name | Ito Makoto |
Kanazawa university Graduate School of Medical Science
Department of Otolaryngology, Head and Neck Surgery
13-1 Takaramachi Kanazawa, Ishikawa
076-265-2413
makoto@med.kanazawa-u.ac.jp
Kanazawa university Graduate School of Medical Science Department of Otolaryngology, Head and Neck Surgery
Ministry of Health, Labour and Welfare
Japan
NO
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)
2009 | Year | 12 | Month | 12 | Day |
Unpublished
Completed
2009 | Year | 10 | Month | 15 | Day |
2009 | Year | 12 | Month | 01 | Day |
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 11 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2009 | Year | 12 | Month | 10 | Day |
2012 | Year | 07 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003505
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