Evaluation of the safety and efficacy of transgenic rice containing peptides from Japanese cedar pollen allergens.
- Conditions
- Adult patient with Japanese cedar pollinosis.
- Registration Number
- JPRN-UMIN000011086
- Lead Sponsor
- The Jikei University, School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 43
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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/)
- Secondary Outcome Measures
Name Time Method 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