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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025470
Receipt No. 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

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Basic information
Public title Efficacy of Kakkonto in oral immunotherapy for food Allergy : Randomized Controlled Trial
Acronym Efficacy of oral immunotherapy combinated Kakkonto
Scientific Title Efficacy of Kakkonto in oral immunotherapy for food Allergy : Randomized Controlled Trial
Scientific Title:Acronym Efficacy of oral immunotherapy combinated Kakkonto
Region
Japan

Condition
Condition food allergy
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Efficacy of oral immunotherapy induced acute reactions and side reaction by Kakkonto
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Combination of anti-allergic drug and Kakkonto at introduction of oral immunotherapy for 5weeks
Interventions/Control_2 Combination of anti-allergic drug at introduction of oral immunotherapy for 5weeks
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
4 years-old <=
Age-upper limit
15 years-old >
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Adachi
Organization Toyama University Hospital
Division name Pediatrics
Zip code
Address 2630 Sugitani, Toyama, Japan
TEL 81.76.434.2281
Email toyamakoit-group@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori Ito
Organization Toyama University Hospital
Division name Pediatrics
Zip code
Address 2630 Sugitani, Toyama, Japan
TEL 81.76.434.2281
Homepage URL
Email yaitto-tym@umin.net

Sponsor
Institute Toyama University
Institute
Department

Funding Source
Organization Toyama University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 29 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 Terminated
Date of protocol fixation
2016 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 26 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 09 Month 18 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 29 Day
Last modified on
2018 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029315

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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