Healthy Japanese subjects
Conditions
Interventions
The test food Duration: 15 weeks
The placebo food Duration: 15 weeks
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who have eyes and nose discomfort by pollen at last two years 6. Subjects who do not use antiallergic drugs (except for who sometimes use them for eyes and nose discomfort by pollen) 7. Subjects who are judged as eligible to participate in the study by the physician 8. Subjects who received a full explanation on the objectives and methods of the study, who have the ability to consent, who well understood the study, and who themselves voluntarily provided consent for study participation.
Exclusion criteria
Exclusion criteria: Subjects (who) 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage at least four times a week 5. take functional food/beverage that may affect allergic reaction, such as beta-carotene, methylated catechins, lactic acid bacteria, bifidobacteria, rosmarinic acid, acetic acid bacteria, soy fermented polysaccharides, caffeic acid, luteolin, quercetin, hesperidin, or nobiletin at least four times a week 6. drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 7. currently taking medications (including herbal medicines) and supplements 8. 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 9. are allergic to medications and/or the test-food-related products (particularly gelatin) 10. have a nasal irrigation habit 11. do not go out more than once a week 12. are pregnant, lactation, or planning to become pregnant 13. have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 14. are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of allergic reaction of eyes and nose | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed