A Confirmatory Study of decreasing effect of uncomfortable feelings in nose and eyes by consumption of test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000052952
- Lead Sponsor
- Synapse planning Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 66
Not provided
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who are allergic to medicines and/or the test food related products (particularly, plant A, plant A oil, plant B, or plant B oil) 3. Subjects who are currently, exercise therapy and diet therapy are performed/ planning to under the supervision of a physician 4. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 5. Subjects who are 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 who are currently taking medicines, foods for specified health uses, health foods, etc. (e.g. vitamins, lactic acid drinks/supplements for the purpose of alleviating discomfort in the eyes and/or nose.) 7. Subjects who have a nasal irrigation habit 8. Subjects who do not go out more than once a week 9. Subjects whose eating habit is extremely irregular 10. Subjects who are routinely drinking a large amount of alcohol. 11. Subjects whose life rhythms are irregular due to shift work, night work, or others 12. Subjects who have been enrolled in other clinical trials within one month before the agreement to participate in this trial or plan to participate another trial during this trial 13. 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 Japanese rhino-conjunctivitis quality of life questionnaire (JRQLQ)
- Secondary Outcome Measures
Name Time Method 1. Grading the severity of allergic rhinitis 2. Medical examination for check subjects nasal and eye symptom survey and nasal condition 3. The number of eosinophils in nasal discharge and specific IgE (Four types: Japanese red-cedar, cypress, Dermatophagoides pteronyssinus, and house dust)