Healthy Japanese subjects
Conditions
Interventions
Duration: 4 weeks Test Material: Active capsule Dosage: Take 3 capsules any time during the day with water or warm water * If you forget to take the capsules, take capsules as soon as you remembe
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are experiencing discomfort in their eyes and nose 3. Subjects who are judged as eligible to participate in the study by the physician 4. Within the subjects who met the 1st to 3rd inclusion criteria, subjects whose total QOL score of JRQLQ No1 is relatively high at screening (before consumption)
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Currently 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 3. Subjects who are diagnosed with pollen allergy 4. Subjects who are diagnosed with allergic rhinitis 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who could have an allergy to raw materials of the test food, or possible to have serious allergic reactions to other foods and/or medicines 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 10. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Japanese rhino-conjunctivitis quality of life questionnaire (JRQLQ No1) * Assess the items at screening (before consumption) and 4 weeks after consumption. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Questionnaire based on practical guideline for the management of allergic rhinitis in Japan (record in the diary report) sneezing, runny nose, blocked nose, itchy eyes, and watery eyes 2. Specific IgE (Dermatophagoides pteronyssinus, animal dander, Japanese red-cedar, orchard grass, timothy grass, ragweed, and moth) 3. Eosinophils in the nasal discharge *1 Record the daily report every day from 1 week before starting consumption. *2, 3 Assess the items at screening (before consumption) and 4 weeks after consumption. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed