None listed
Conditions
Interventions
Intake two packs of test food a day for eight weeks.
Intake two packs of control food a day for eight weeks.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females aged 20 to 64 when informed consent, who match the inclusion criteria (2) and (4) or (3) and (4) as be shown below. 2) Healthy subjects who have, include used to have, nose allergy. And healthy subjects who don't and/or won't use allergy treatment medicines, before the test and/or during the test period. 3) Light symptom subjects who have, include used to have, nose allergy. And those subjects who will use allergy treatment medicines sometimes (not regularly), before the test and/or during the test period. 4) Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Exclusion criteria
Exclusion criteria: 1) Subjects who plan some treatment during test period. 2) Subjects who use oral steroid medicine in order to treatment allergy. 3) Subjects who regularly use and/or are not able to quit use medicines, quasi-drugs and herbal medicines those have the inhibition effects of allergy and concerned to give influence for test results. 4) Subjects who regularly use and/or are not able to quit use healthy foods those advocate to have the inhibition effects of allergy and concerned to give influence for test results. 5) Females who are pregnant or could become pregnant, and who are lactating. 6) Subjects who have previous and/or current medical history of serious disease 7) Subjects who use oral medicines and/or nasal drops those are antihistamine or anti-allergy 8) Subjects who don't intake test food and/or don't enter the Web diary against the instruction of administrator during test period. 9) Subjects who excessive alcohol intake. 10) Subjects who have non-allergic nasal inflammation 11) Subjects who can't eat lotus root 12) Subjects who have food allergy 13) 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. 14) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. 15) Males who donated over 400mL blood within the last three months to the current study. 16) Females who donated over 400mL blood within the last four months to the current study. 17) Males who will be collected over 1200mL blood, when the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study. 18) Females who will be collected over 800mL blood when, the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study. 19) Others who have been determined ineligible by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nasal symptom score of JRQLQ | — |
Secondary
| Measure | Time frame |
|---|---|
| * Nasal symptom score for severity classification of allergies * Nasal examination * Ocular symptoms score * QOL score * Concentration of serum non-specific IgE * Concentration of serum specific IgE against CAP16 * White blood cell image * Nasal discharge neutrophils * Medication Score * Incidence of adverse events and side effects | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Planning & Sales Department
Outcome results
None listed