Healthy adult
Conditions
Interventions
Intake 60 mL of test food a day, 12 consecutive weeks.
Intake 60 mL of placebo food a day, 12 consecutive weeks.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Male and female aged 20 to 59 when consent acquisition. (2)Subjects who can intake test food every day. (3)Subjects who notice themselves as they are mild/moderate hay fever and/or perennial allergic rhinitis. (4)Subjects giving written informed consent.
Exclusion criteria
Exclusion criteria: (1) Subjects who have treated or taken medicine for perennial allergic rhinitis from 4 weeks before advance inspection to the end of the study. (2) Subjects who planning some treatment during the examination period. (3) Subjects who intake the medicines, the foods for specified health uses (FOSHU) and/or the health foods those are concerned their influence to test results. (4) Pregnant or expected pregnant, and lactating women. (5) Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney. (6) Subjects who excessive alcohol intake. (7) Subjects who have smoking habit. (8) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. (9) Subjects who have previous medical history of drug and/or food, allergy, especially for Shiso leaf. (10) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (11) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (12) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. (13) Females who donated over 400mL blood and/or blood components within the last four month to the current study. (14) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (15) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (16) Others who have been determined ineligible by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Japan Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: nasal eosinophils, nonspecific IgE, Allergen-specific IgE (for 16 allergens), histamine, TNF-alpha. Safety evaluation outcomes: physiological examination, hematological examination, blood biochemical examination, urine examination, presence or absence of side effects and adverse events during the test. | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Co., Ltd. Sales & Planning division
Outcome results
None listed