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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037991
Receipt No. R000042913
Scientific Title Efficacy of dewaxed brown rice on the symptoms of pollinosis. An open-label, randomized, parallel-group comparative study.
Date of disclosure of the study information 2019/12/01
Last modified on 2019/08/09

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Basic information
Public title Efficacy of dewaxed brown rice on the symptoms of pollinosis.
An open-label, randomized, parallel-group comparative study.
Acronym Efficacy of dewaxed brown rice on the symptoms of pollinosis.
Scientific Title Efficacy of dewaxed brown rice on the symptoms of pollinosis.
An open-label, randomized, parallel-group comparative study.
Scientific Title:Acronym Efficacy of dewaxed brown rice on the symptoms of pollinosis.
Region
Japan

Condition
Condition Pollinosis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy of dewaxed brown rice on the symptoms of pollinosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The QOL score
Key secondary outcomes Blood biochemical test
Total nasal symptom score
Total ocular symptom score

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 Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Dewaxed brown rice intake
Interventions/Control_2 Control food 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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) Subjects who agree to participate in the current study with a written informed consent.
2) Subjects with symptoms of pollinosis at scattering period of pollen in the past 2 years.
Key exclusion criteria 1) Subjects with nasal and oculer disease that affects the evaluation of the study.
2)Subjects with serious cardiac, cerebrovascular, renal, hepatic and / or metabolic and endocrine disorders, or affected with infectious diseases.
3) Subjects who intake brown rice and cereals for 3 days or more a week.
4) Subjects with allergic to test food.
5) Subjects treated with immunotherapy.
6) Pregnant women and those at risk of pregnancy and lactating women.
7) Subjects who the doctor judged inappropriate for the study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Maya
Middle name
Last name Uenobe
Organization The University of Nagano
Division name Faculty of Health and Human Development Department of Food and Health Sciences
Zip code 3808525
Address 8-49-7 Miwa, Nagano City, Nagano
TEL 0262172241
Email uenobe.maya@u-nagano.ac.jp

Public contact
Name of contact person
1st name Maya
Middle name
Last name Uenobe
Organization The University of Nagano
Division name Faculty of Health and Human Development Department of Food and Health Sciences
Zip code 3808525
Address 8-49-7 Miwa, Nagano City, Nagano
TEL 0262172241
Homepage URL
Email uenobe.maya@u-nagano.ac.jp

Sponsor
Institute The University of Nagano
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The University of Nagano
Address Faculty of Health and Human Development Department of Food and Health Sciences
Tel 0262712241
Email uenobe.maya@u-nagano.ac.jp

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 長野県立大学(長野県)、那珂川病院(福岡県)

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 09 Month 11 Day
Last modified on
2019 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042913

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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