Unique ID issued by UMIN | UMIN000024699 |
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Receipt number | R000028415 |
Scientific Title | Verification of suppressing effects of Japanese cedar pollen peptide-containing rice on symptoms and IgE associated with Japanese cedar pollinosis (Study 1) |
Date of disclosure of the study information | 2016/11/04 |
Last modified on | 2018/12/03 11:54:14 |
Verification of suppressing effects of Japanese cedar pollen peptide-containing rice on symptoms and IgE associated with Japanese cedar pollinosis (Study 1)
Verification of suppressing effect of Japanese cedar pollen peptide-containing rice on symptoms associated with Japanese cedar
pollinosis
Verification of suppressing effects of Japanese cedar pollen peptide-containing rice on symptoms and IgE associated with Japanese cedar pollinosis (Study 1)
Verification of suppressing effect of Japanese cedar pollen peptide-containing rice on symptoms associated with Japanese cedar
pollinosis
Japan |
Japanese cedar pollinosis
Clinical immunology |
Others
NO
Verification of suppressing effect of Japanese cedar pollen peptide-containing rice on symptoms associated with Japanese cedar
pollinosis
Safety,Efficacy
Confirmatory
Explanatory
Phase II
symptoms of cedar pollen allergy from 12 weeks to 24 weeks after the start of ingestion
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
3
Treatment
Food |
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)
2)the same 5g intake group (allergy rerief rice 5g plus pracebo rice 45g once a day, for 24 weeks, 15 cases)
3)the placebo group (allergy rerief rice 0g plus pracebo rice 50g once a day, for 24 weeks, 15 cases)
20 | years-old | <= |
70 | years-old | > |
Male and Female
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
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
45
1st name | |
Middle name | |
Last name | Shoji Hashimoto |
Osaka Habikino Medical Center
Department of Clinical Reseach & Development
3-7-1 Habikino Habikino city Osaka
072-957-2121
hashisyo@ra.opho.jp
1st name | |
Middle name | |
Last name | Shoji Hashimoto |
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Department of Clinical Reseach & Development
3-7-1 Habikino Habikino city Osaka
072-957-2121
hashisyo@ra.opho.jp
Osaka Habikino Medical Center
Osaka Habikino Medical Center
Self funding
Department of Clinical Application of Biologics, Osaka University Graduate School of Medicine
NO
(地独)大阪はびきの医療センター
2016 | Year | 11 | Month | 04 | Day |
Unpublished
No longer recruiting
2016 | Year | 09 | Month | 12 | Day |
2016 | Year | 09 | Month | 16 | Day |
2016 | Year | 11 | Month | 03 | Day |
2018 | Year | 12 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028415
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