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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035115
Receipt No. R000040025
Official scientific title of the study Verification of the prevention effect of daily high-dose Japanese cedar pollen peptide-containing rice on onset from non-onset of Japanese cedar pollinosis(Study3)
Date of disclosure of the study information 2018/12/04
Last modified on 2018/12/03

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Basic information
Official scientific title of the study Verification of the prevention effect of daily high-dose Japanese cedar pollen peptide-containing rice on onset from non-onset of Japanese cedar pollinosis(Study3)
Title of the study (Brief title) Verification of the prevention effect of daily high-dose Japanese cedar pollen peptide-containing rice on onset from non-onset of Japanese cedar pollinosis
Region
Japan

Condition
Condition Japanese cedar pollinosis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of the prevention effect of daily high-dose Japanese cedar pollen peptide-containing rice on onset from non-onset of Japanese cedar pollinosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Japanese cedar pollen-specific T cell proliferative response at 0, 4, 8 weeks after the start of ingestion
Key secondary outcomes 1)serum Japanese cedar pollen-specific IgE antibody level at 0, 4, 8 weeks after the start of ingestion
2)adverse events from the start to the end of ingestion

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 1)Japanese cedar pollen allergy relief rice 80g intake group (allergy rerief rice 80g once a day, for 8 weeks, 7cases)
Interventions/Control_2 2)the placebo group (pracebo rice 80g once a day, for 8 weeks, 3 cases)
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1)those who have no symptoms related allergic rhinitis consistent with the cedar pollen season
2)those whose Japanese cedar pollen allergen-specific IgE antibody titer show class the 2 or 3 (measured by AlaSTAT 3g method)
3)those whose Japanese ceder pollen-specific T cell proliferative response show positive
4)those who live or work in Osaka prefecture and consented to research participation by the document from the person obtained
5)those who can comply with not to transfer the test product to a third party
Key exclusion criteria 1)those whom Principal Investigator or the sharing researchers have determined inappropriate
2)those who suffer from rice allergy or have a history of rice allergy
3)those who have received immunotherapy for cedar pollen, or have the schedule
4)those who suffer from some serious disease with disease activity, therefore, are judged unsuitable for enrolement by the clinician
5)those who are or planning to become pregnant or in the process of breast-feeding during the clinical reseach
6)those who are participating in other clinical research
Target sample size 10

Research contact person
Name of lead principal investigator Shoji Hashimoto
Organization Osaka Habikino Medical Center
Division name Department of Clinical Research & Development
Address 3-7-1 Habikino Habikino city Osaka
TEL 072-957-2121
Email hashisyo@ra.opho.jp

Public contact
Name of contact person Shoji Hashimoto
Organization Osaka Habikino Medical Center
Division name Department of Clinical Research & Development
Address 3-7-1 Habikino Habikino city Osaka
TEL 072-957-2121
Homepage URL
Email hashisyo@ra.opho.jp

Sponsor
Institute Osaka Habikino Medical Center
Institute
Department

Funding Source
Organization Osaka Habikino Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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 (地独)大阪はびきの医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 04 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 09 Month 13 Day
Anticipated trial start date
2018 Year 11 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 12 Month 03 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040025

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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