UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of suppressing effects of Japanese cedar pollen peptide-containing rice on symptoms and IgE associated with Japanese cedar pollinosis (Study 1)
Title of the study (Brief title)	Verification of suppressing effect of Japanese cedar pollen peptide-containing rice on symptoms associated with 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 suppressing effect of Japanese cedar pollen peptide-containing rice on symptoms associated with 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	symptoms of cedar pollen allergy from 12 weeks to 24 weeks after the start of ingestion
Key secondary outcomes	1)use of the therapeutic agent and QOL for cedar pollen allergy from 12 weeks to 24 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	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	1)Japanese cedar pollen allergy relief rice 20g intake group (allergy rerief rice 20g plus pracebo rice 30g once a day, for 24 weeks, 15 cases)
Interventions/Control_2	2)the same 5g intake group (allergy rerief rice 5g plus pracebo rice 45g once a day, for 24 weeks, 15 cases)
Interventions/Control_3	3)the placebo group (allergy rerief rice 0g plus pracebo rice 50g once a day, for 24 weeks, 15 cases)
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 presented with symptoms related allergic rhinitis such as sneezing, nasal discharge, obstruction and eye itching for at least 2 continuous years, consistent with the cedar pollen season 2)those whose Japanese cedar pollen allergen-specific IgE antibody titer show class the 2 or more (measured by AlaSTAT 3g method) 3)those whose Japanese cypress pollen-specific IgE antibody titer show the class 4 or less(AlaSTAT 3g) 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 whose pets (dogs, cats) and house dust and mite-specific IgE antibody titers show the class of 5 or more, ond who are breeding a pet. 4)those whose house dust and mite-specific IgE antibody titer, swow higher than the cedar pollen-specific IgE antibody titers 5)those who have received immunotherapy for cedar pollen, or have the schedule 6)those who suffer from some serious disease with disease activity, therefore, are judged unsuitable for enrolement by the clinician 7)those who are or planning to become pregnant or in the process of breast-feeding during the clinical reseach 8)those who are participating in other clinical research
Target sample size	45

Research contact person
Name of lead principal investigator	Shoji Hashimoto
Organization	Osaka Habikino Medical Center
Division name	Department of Clinical Reseach & 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 Prefectural Medical Center for Respiratory and Allergic Diseases
Division name	Department of Clinical Reseach & 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	Department of Clinical Application of Biologics, Osaka University Graduate School of Medicine
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	2016 Year 11 Month 04 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 09 Month 12 Day
Anticipated trial start date	2016 Year 09 Month 16 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	2016 Year 11 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/icdr_e/ctr_view.cgi?recptno=R000028415