UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037991 |
|---|---|
| Receipt number | 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 | 2022/03/18 10:48:55 |
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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
Japan Rhinitis Quality of Life Questionnaire
No.1(JRQLQ No.1)
Key secondary outcomes
Blood biochemical test
Total nasal symptom score
Total ocular symptom score
Medication 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
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
uenobe.maya@u-nagano.ac.jp
Sponsor or person
Institute
The University of Nagano
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 23 | Day |
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
| 2022 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042913
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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