UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012021 |
|---|---|
| Receipt number | R000011136 |
| Scientific Title | Effect of daily intake of banana on cedar pollen-induced allergy in Japanese patients |
| Date of disclosure of the study information | 2013/10/11 |
| Last modified on | 2018/02/26 14:48:20 |
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Basic information
Public title
Effect of daily intake of banana on cedar pollen-induced allergy in Japanese patients
Acronym
Banana diet and cedar pollen allergy
Scientific Title
Effect of daily intake of banana on cedar pollen-induced allergy in Japanese patients
Scientific Title:Acronym
Banana diet and cedar pollen allergy
Region
| Japan |
Condition
Condition
Cedar pollen allergy
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine if daily intake of banana ameliorates symptoms and signs of Cedar pollen allergy in humans.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nasal allergy score
Nasal allergy QOL score
Key secondary outcomes
blood eosinohil count
serum level of cedar pollen specific IgE
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of banana
Interventions/Control_2
prohibition of banana intake
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with cedar pollen allergy who have both the following conditions.
1) diagnosed as mild or moderate according the guideline 2009 for nasal allergy
2) confirmed to have positive serum level of cedar pollen specific IgE.
Key exclusion criteria
Patients with cedar pollen allergy who have at least one of the following conditions.
1) diagnosed as severe or extremely severe according the guideline 2009 for nasal allergy
2) regular use of steroid-containg drugs for the treatment of nasl allergy
3) regular use of steroid or immunosuppresive drugs
4) diagnosed as diabetis mellitis
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinori Yanaka |
Organization
University of Tsukuba Hospital
Division name
Hitachi Medical Education and Research Center
Zip code
Address
2-1-1, Jonan-cho, Hitachi, Ibaraki 317-0077
TEL
0294-23-1111
ynk-aki@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akinori Yanaka |
Organization
University of Tsukuba Hospital
Division name
Hitachi Medical Education and Research Center
Zip code
Address
2-1-1 Jonan-cho, Hitachi-shi, Ibaraki-ken
TEL
0294-23-11111
Homepage URL
ynk-aki@md.tsukuba.ac.jp
Sponsor or person
Institute
Hitachi Medical Education and Research Center, Univeristy of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japan Banana Importers Association
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 10 | Month | 11 | 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
| 2012 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 11 | Day |
Last modified on
| 2018 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011136
