A study to evaluate eye and nose discomfort: a randomized, placebo-controlled, double-blind, parallel-group comparison study
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000049884
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 180
Not provided
1. Subjects receiving treatment for perennial rhinitis 2. Subjects undergoing specific sensitization therapy or surgical therapy for hay fever 3. Subjects who use or take steroidal drugs for drug treatment of hay fever 4. Subjects who reported nasal disease (acute or chronic rhinitis, sinusitis, rhinophyma, hypertrophic rhinitis, or nasal septal deformity) 5. Subjects who have been reported as severe or most severely ill in the severity assessment of allergic rhinitis 6. Subjects suffering from certain diseases except hay fever and receiving outpatient medication 7. Subjects with a history or current history of serious hepatic disorder, renal disorder, cardiac disease, or severe anemia 8. Subjects with a current history of bronchial asthma or those taking anti-allergy medication for atopic dermatitis, asthma, etc. 9. Subjects who may show allergic symptoms to any of the research food ingredients 10. Subjects who who take medicines (such as lactobacillus preparations) that may affect test results, or who routinely consume health foods 11. Subjects with gastrointestinal diseases affecting digestion and absorption, and persons with a history of gastrointestinal surgery 12. Subjects who habitually drink excessive amounts of alcohol, exceeding approximately 60 g of pure alcohol equivalent per day, five or more days per week 13. Subjects with extremely irregular eating habits, shift workers, late-night workers, or those with irregular life rhythms 14. Pregnant, lactating, or intending to become pregnant 15. Subjects who have donated more than 200 mL of blood or component blood within 4 weeks of the screening test or 400 mL within 3 months of the screening test 16. Subjects who have participated in other studies within 1 month of obtaining consent, and those who are willing to participate 17. Subjects who are judged as ineligible to participate in this study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The Japanese allergic rhinitis quality of life questionnaire 2. The grading severity of allergic rhinitis questionnaire
- Secondary Outcome Measures
Name Time Method 1. Local findings in nasal cavity 2. Cedar pollen-specific IgE antibody levels 3. Eosinophils, LD(IFCC)