N/A(healthy adults)
Conditions
Interventions
Oral ingestion of the test food (6 tablets once a day for 12 weeks)
Oral ingestion of the placebo food (6 tablets once a day for 12 weeks)
Sponsors
TES Holdings Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese males and females aged 20-65 years. [2]Individuals who are healthy and are not suffered from a chronic malady. [3]Individuals with allergic rhinitis-symptoms. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can visit an inspection facility and be inspected in designated days. [6]Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals whose grade for the severity of allergic rhinitis is "severe" or "most severe". [2]Individuals who visit a hospital or use a drug to treat perennial allergic rhinitis or pollinosis (except using nose drops and eye drops of category-3 OTC). [3]Individuals using medical products. [4]Individuals who are a patient of or have a history of bronchial disease. [5]Individuals who are patient or have a history of mental disease, psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [6]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [7]Individuals who are sensitive to a test food, other foods, and medical products. [8]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease. [9]Individuals who are a patient or have a history of or endocrine disease. [10]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [11]Individuals who had an experience of side effects on blood sampling such as bad feeling or poor physical condition. [12]Individuals who ingest food for specified health uses or foods with Function Claims (except individuals who can stop ingesting these food before an informed consent). [13]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [14]Individuals whose life style will change during the test period. [15]Individuals who are or are possibly, or are lactating. [16]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [17]Individuals who are or whose family is engaged in healthy or functional foods. [18]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Indexes for allergic rhinitis (grading the severity of allergic rhinitis [Week 0, 4, 8, 12]; grading of local findings [Week 0, 4, 8, 12]; effect measurement [Week 12]; Japan Rhinitis Quality of Life Questionnaire No. 1 [Week 0, 2, 4, 6, 8, 10, 12]) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]Nasal discharge eosinophils (Week 0, 12) [2]Blood IgE (Week 0, 12) [3]Japanese edition of Profile of Mood States (2nd edition) (Week 0, 4, 8, 12) *Safety evaluation [1]Hematologic test (Week 0, 4, 8, 12) [2]Blood biochemical test (Week 0, 4, 8, 12) [3]Urine analysis (Week 0, 4, 8, 12) [4]Blood pressure, pulsation (Week 0, 4, 8, 12) [5]Weight, body fat percentage, BMI (Week 0, 4, 8, 12) [6]Doctor's questions (Week 0, 4, 8, 12) *Other indexes [1]Questionnaire for allergic rhinitis (Week 0) [2]Subject's diary(From the first day of ingestion of a test material to the last day of the test) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd Administrative Department of Clinical Trials
Outcome results
None listed