Unique ID issued by UMIN | UMIN000011086 |
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Receipt number | R000012979 |
Scientific Title | Evaluation of the safety and efficacy of transgenic rice containing peptides from Japanese cedar pollen allergens. |
Date of disclosure of the study information | 2013/07/01 |
Last modified on | 2014/12/29 11:24:43 |
Evaluation of the safety and efficacy of transgenic rice containing peptides from Japanese cedar pollen allergens.
Evaluation of the safety and efficacy of transgenic rice containing peptides from Japanese cedar pollen allergens.
Evaluation of the safety and efficacy of transgenic rice containing peptides from Japanese cedar pollen allergens.
Evaluation of the safety and efficacy of transgenic rice containing peptides from Japanese cedar pollen allergens.
Japan |
Adult patient with Japanese cedar pollinosis.
Oto-rhino-laryngology |
Others
NO
The examination aiming to evaluate safety and efficacy.
Safety,Efficacy
Based on the group of placebo rice ingestion as a reference, evaluate the difference in sum of severity degree of nasal symptoms such as sneezing, nasal secretion, and nasal congestion to be compared between BEFORE and AFTER the pollination season.
Furthermore, according to the information of the biggining day of cedar pollination spread, announced on the pollen report site of Ministery of the Environment (http://www.env.go.jp/chemi/anzen/kafun/)
Efficacy **Following items are to be compared in between BEFORE and AFTER the pollination season**
- Total score of intranasal observation
- Total score of intradermal reaction and number of nasal eosinophil
- Immunological test (Change of reactive T-cell)
- Score of Japanese Allergic Rhinitis Standard QOL Questionnaire (JRQLQ)
- Total score of nasal symptoms (Sneezing score, Nasal secretion score, and Nasal congestion score) reported by allergic diary
Safety
- Subjective symptom and Objective symptom (medical interview, allergic diary)
- Changes in laboratory values
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Prevention
Medicine |
Evaluation on the safety of 80g of transgenic rice containing peptides from Japanese cedar pollen allergens among few subjects.
Evaluation of the safety and efficacy of 80g of transgenic rice containing peptides from Japanesse cedar pollen allergens by comparing between oral ingestion group of 80g or transgenic rice and it is of 80g of placebo rice.
20 | years-old | <= |
Not applicable |
Male and Female
1) Adult aged over 20years old and lives or works in Tokyo.
2) P person who has allergic symptoms such as sneezing, running nose, and nasal obstruction.
3) A person who gives a positive result in provocative test and intradermal test (please refer to appendix for an assessment procedures)
4) Cedar pollen allergen-specific IgE antibody values over Class II.
5) Cypress specific IgE antibody values under Class IV.
1) A person who is allergic to Rice or has a history of Rice allergy.
2) A person who shows Pet/House dust specific IgE antibody valued over Class V, and has pet (dogs and cats).
3) A person who is imperative to use medicine such as anti-allergic agent and steroidal chemicals that potentially influence the outcome of evaluation.
4) A person who underwent an operation that is accompanied to nasal disorder within last 2years, or has nasal disorder such as acute/chronic-rhinitis, rhinopolypus, hypertronic rhinitis, septal deviation, sinusitis which all are potentially hinder to the outcome of evaluation.
5) A person who ever received immunotherapy in the past.
6) A person who has any disorders under treatment and the condition is unstable that trial investigator has asessed as mismatched participant.
7) A person who has a history of serious disorder such as diabetes, hepatic disorder, kidney disorder, and cardiac disorder.
8) A person who takes beta-blocker in order to treat complecating disorders such as hypertension, and / or cardiac disorder.
9) A person who takes alpha-blocker in order to treat complecating disorders such as prostatic hyperplasia.
10) A person who is complecated by immunodeficiency disorder, cancer, or severe enemia.
11) A person who is complecated by severe asthma.
12) A person who'S pre-clinical test showed AST(GOT), ALT(GRT), Creatinine or BUN value exceed 1.5 times the upper limit or normal, or has other laboratory abonormalities that trial investigator has assessed as mismatched participant.
13) A person who participates in other clinical test at the onset of this test.
14) A person who is presently breastfeeding, pregnant, or planning/wishing to be a pregnant during a period of this clinical test.
15) A person whom trial investigator has asessed as mismatched participant.
43
1st name | |
Middle name | |
Last name | Saburo Saito |
The Jikei University, School of Medicine.
Department of Molecular Immunology
3-25-8 Nishi Shinbashi, Minato-ku, Tokyo, 105-8461 JAPAN.
03-3433-1111
misaburo@jikei.ac.jp
1st name | |
Middle name | |
Last name | Daiya Asaka |
The Jikei University, School of Medicine.
Dpartment of Otorhinolaryngology
3-25-8 NIshi Shinbashi, Minato-ku, Tokyo 105-8461 Japan
03-3433-1111
asaka@jikei.ac.jp
The Jikei University, School of Medicine
Agri-Health Translational Research Project
Japan
National Institute o Agrobiological Sciences (NIAS)
SATAKE Corporation
NO
東京慈恵会医科大学附属病院
2013 | Year | 07 | Month | 01 | Day |
Unpublished
Completed
2013 | Year | 06 | Month | 19 | Day |
2013 | Year | 09 | Month | 18 | Day |
2014 | Year | 07 | Month | 10 | Day |
2014 | Year | 07 | Month | 30 | Day |
2014 | Year | 08 | Month | 20 | Day |
2014 | Year | 10 | Month | 31 | Day |
2013 | Year | 07 | Month | 01 | Day |
2014 | Year | 12 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012979
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