Unique ID issued by UMIN | UMIN000030175 |
---|---|
Receipt number | R000034465 |
Scientific Title | Efficacy of oral tolerance induction by Kakkonto in food allergy |
Date of disclosure of the study information | 2017/12/15 |
Last modified on | 2022/06/03 09:03:13 |
Efficacy of oral tolerance induction by Kakkonto in food allergy
Efficacy of Kakkonto for food allergy
Efficacy of oral tolerance induction by Kakkonto in food allergy
Efficacy of Kakkonto for food allergy
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.
Efficacy
Exploratory
Pragmatic
Not applicable
1. Induced reaction during 24 weeks of treatment
2. Change of dose threshold in oral food challenge after 24 weeks of treatment
3. adverse reaction of kakkonto
4. Specific IgE/IgG4 antibody, cytokines, lymphocytes subsets
5. Prick test
6. Compliance of kakkonto
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Take an intake instruction in a safe amount for a patient who is positive for oral food challenge test. We used Kakkonto for 24 weeks together and reevaluated the change in threshold by oral food challenge test.
Take an intake instruction in a safe amount for a patient who is positive for oral food challenge test. We reevaluated the change in threshold by oral food challenge test.
2 | years-old | <= |
20 | 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 | Yuichi |
Middle name | |
Last name | Adachi |
Toyama University Hospital
Pediatrics
930-0194
2630 Sugitani, Toyama, Japan
81.76.434.2281
toyamakoit-group@umin.ac.jp
1st name | Yasunori |
Middle name | |
Last name | Ito |
Toyama University Hospital
Pediatrics
930-0194
2630 Sugitani, Toyama, Japan
81.76.434.2281
yaitto-tym@umin.net
Toyama University
Toyama University
Other
toyama univ
Toyama university
2630 sugitani, toyama, japan
0764342281
yaitto-tym@umin.net
NO
富山大学付属病院
2017 | Year | 12 | Month | 15 | Day |
Unpublished
Terminated
2017 | Year | 11 | Month | 13 | Day |
2017 | Year | 11 | Month | 27 | Day |
2017 | Year | 11 | Month | 27 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 03 | Month | 31 | Day |
2017 | Year | 11 | Month | 29 | Day |
2022 | Year | 06 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034465