Evaluation of the safety and efficacy of low dose transgenic rice containing peptides from Japanese cedar pollen allergens.

Not Applicable

• Conditions: Adult patients with Japanese cedar pollinosis.

• Registration Number: JPRN-UMIN000016078
• Lead Sponsor: The Jikei University, School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-29
• Study Completion: 2015-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

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 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'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. 12) A person who participates in other clinical test at the onset of this test. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified