Unique ID issued by UMIN | UMIN000025470 |
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Receipt number | R000029315 |
Scientific Title | Efficacy of Kakkonto in oral immunotherapy for food Allergy : Randomized Controlled Trial |
Date of disclosure of the study information | 2016/12/29 |
Last modified on | 2018/09/18 12:44:52 |
Efficacy of Kakkonto in oral immunotherapy for food Allergy : Randomized Controlled Trial
Efficacy of oral immunotherapy combinated Kakkonto
Efficacy of Kakkonto in oral immunotherapy for food Allergy : Randomized Controlled Trial
Efficacy of oral immunotherapy combinated Kakkonto
Japan |
food allergy
Clinical immunology | Pediatrics |
Others
NO
Oral immunotherapy has been conducted for food allergy, but there are also many unresolved problems in safety due to strong allergic reactions.
Kakkonto, a traditional Japanese medicine, is reported to have an effect of suppressing the onset of food allergy in a mouse food allergy pathology model and may be an adjunctive treatment for oral immunotherapy for food allergy.
In this study, we evaluate the efficacy and safety by Kakkonto in combination with food allergy.
Safety
Exploratory
Pragmatic
Not applicable
Efficacy of oral immunotherapy induced acute reactions and side reaction by Kakkonto
1.Change of dose threshold in oral food challenge after 24 weeks of treatment
2.Specific IgE/IgG4 antibody, cytokines, lymphocytes subsets
3.Prick test
4.Compliance of kakkonto
5.Induced reactions during the maintenance
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
YES
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
Combination of anti-allergic drug and Kakkonto at introduction of oral immunotherapy for 5weeks
Combination of anti-allergic drug at introduction of oral immunotherapy for 5weeks
4 | years-old | <= |
15 | years-old | > |
Male and Female
1.Food allergy diagnosised by oral food challenge without tendency of natural outgrow
2. Children who obtain the informed consent of the study
3. Those who can take medicine of kakkonto
4. Patients who have secured medical institutions in emergency
1.Complication or past history of heart, liver and kidney diseases.
2.Uncontrolled asthma, atopic dermatitis, allergic rhinitis
3.Children who were judged as inappropriate by the study director
60
1st name | |
Middle name | |
Last name | Yuichi Adachi |
Toyama University Hospital
Pediatrics
2630 Sugitani, Toyama, Japan
81.76.434.2281
toyamakoit-group@umin.ac.jp
1st name | |
Middle name | |
Last name | Yasunori Ito |
Toyama University Hospital
Pediatrics
2630 Sugitani, Toyama, Japan
81.76.434.2281
yaitto-tym@umin.net
Toyama University
Toyama University
Other
NO
2016 | Year | 12 | Month | 29 | Day |
Unpublished
Terminated
2016 | Year | 12 | Month | 07 | Day |
2016 | Year | 12 | Month | 26 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 09 | Month | 18 | Day |
2016 | Year | 12 | Month | 29 | Day |
2018 | Year | 09 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029315
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