Japanese cedar pollinosis
Conditions
Interventions
Evaluation of the efficacy of oral administration group of 20g of transgenic rice for 24 weeks
Evaluation of the efficacy of oral administration group of 5g of transgenic rice for 24 weeks
Evaluat
Sponsors
The Jikei University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult aged over 20years old and under 70years old and lives or works near The Jikei University School of Medicine. 2) A 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. 6) Stimulation index of T-cell response to allergens over 2.0.
Exclusion criteria
Exclusion criteria: 1) A person who is allergic to Rice or has a history of Rice allergy. 2) A person who shows House dust specific IgE antibody valued over Class V, and has chronic rhinitis 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 has any disorders under treatment and the condition is unstable that trial investigator has asessed as mismatched participant. 6) A person who has a history of serious disorder such as diabetes, hepatic disorder, kidney disorder, and cardiac disorder. 7) A person who takes beta-blocker in order to treat complecating disorders such as hypertension, and / or cardiac disorder. 8) A person who takes alpha-blocker in order to treat complecating disorders such as prostatic hyperplasia. 9) A person who is complecated by immunodeficiency disorder, cancer, or severe enemia. 10) A person who is complecated by asthma. 11) A person who has laboratory abnormalities in the pre-clinical test that trial investigator has assessed as mismatched participant. 12) A person already in another clinical test when this clinical test begins. 13) A person who is presently breastfeeding, pregnant, or planning/wishing to be a pregnant during a period of this clinical test. 14) A person whom trial investigator has asessed as mismatched participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective symptoms -Scoring of allergy diaries between placebo group and transgenic rice group are compared | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Surveys on lifestyles 2.JRQLQ 3.Intranasal observation with rhinoscopy 4.Intradermal reaction, number of nasal eosinophil, total serum IgE and cedar pollen-specific IgE 5.Immunological test:Evaluation of T-cell responses to 7crp, Cry j 1 and cry j 2. 6.Examination of height, weight, BMI,body temperature,blood pressure and pulse count 7.Safety (adverse events) | — |
Countries
Japan
Contacts
Public ContactDaiya Asaka
The Jikei University School of Medicine Department of Otorhinolaryngology
Outcome results
None listed