Healthy Japanese subjects and subjects with mild symptoms
Conditions
Interventions
Duration: Four weeks Test food: Tablets containing flavonoids Administration: Take a total of four tablets per day (two tablets after breakfast and other two tablets after dinner), ingested with wat
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese males and females 2. Subjects with eye and nose discomfort 3. Subjects who are judged as eligible to participate in the trial by the physician 4. Subjects who have relatively high score in the nasal and eye symptoms score of JRQLQ at the point of screening * Among the healthy subjects and those with mild symptoms, more than half of the enrolled subjects will be selected from healthy subjects. a. Healthy subjects: 1. Subjects suffering or having suffered from allergic reactions in their eyes and nose 2. Subjects not using antiallergic drugs before and during the trial b. Subjects with mild symptoms: 1. Subjects suffering or having suffered from allergic reactions in their eyes and nose 2. Subjects who sometimes (not regularly) used ant allergic drugs before and during this trial * "Sometimes" means using a drug as needed. * "Regularly use" means using a drug at fixed intervals even if there are no symptoms.
Exclusion criteria
Exclusion criteria: 1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily intake 5. Subjects receiving long-term drug treatment (Antiallergic drugs, antihistamines, steroids, vasoconstrictors, antihypertensives, etc.) that may affect allergic symptoms of the nose and eyes during the trial 6. Subjects currently regularly taking medications (including herbal medicines) and supplements 7. Subjects allergic to medications and/or the test-food-related products 8. Subjects who cannot take the test food with the prescribed amount and ingestion method 9. Subjects who are planning to go abroad during this trial 10. Subjects who have a nasal irrigation habit 11. Subjects who are lactating, pregnant, or intending to become pregnant 12. Subjects who have been enrolled in other clinical trials within the last three months before the invitation to participate in this trial, or plan to participate in another trial during this trial 13. Subjects who are judged by the physician as ineligible to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured values and changes on scores for each category and items of Japanese Rhino-conjunctivitis Quality of Life Questionnaire questionnaire at two and four weeks after the start of test-food consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| The measured values and changes of subjective symptom scores based on the severity classification measurements of allergic rhinitis, eosinophils in nasal discharge, non-specific IgE, specific IgE (Dermatophagoides pteronyssinus, Japanese red-cedar, cypress, and house dust 1), and all VAS item scores at two and four weeks after the start of test-food consumption | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed