None listed
Conditions
Interventions
Sponsors
APO PLUS STATION CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Males and females from 18 to 64 years of age [2] Subject who did have cold like symptoms in winter within 2 years [3] Subjects who are judged as eligible for the study based on cold like symptoms during pre-treatment observation period and results of the screening test [4] Subjects who have been fully informed of the purpose and content of the study, and submit the written informed consent form
Exclusion criteria
Exclusion criteria: [1] Subjects who have disease requiring medication, and treatment except dry eye and cavity protection, or have a history of serious illness required medications [2] Subjects having the disease past medical history that needed a diet and exercise therapy under the management of the doctor [3] Subjects who having allergic rhinitis, atopic dermatitis, bronchial asthma, and chronic bronchitis [4] Subjects who cannot restrict the use of medicines or health foods that may influence this study after informed consent [5] Subjects who received vaccine shot includes influenza or the corona vaccine within six months before the screening test and hope for vaccination during an intake period [6] Heavy drinkers of alcohol [7] Current smokers [8] Subjects who are planning to travel abroad during the study period, or who are planning of overseas business trip [9] Night and day shift worker [10] Subjects who have participated in other clinical studies within one month before giving consent or plan to participate during the present study period [11] Subjects who are judged as unsuitable for the study based on the results of Wisconsin Upper Respiratory Symptom Survey short versions(WURSS-21)Japanese version [12] Subjects who are judged as unsuitable for the study based on the results of clinical examination or cardiopulmonary abnormality in the past [13] Subjects who have allergy [14] Subjects who are judges as unsuitable for the study based on the result of clinical and physical examination on screening test [15] Subjects who are becoming pregnant and lactating or intend to become pregnant [16] Subjects who may be unable to maintain their daily lifestyle [17] Subjects who are judged as unsuitable for the study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1] Cumulative days with each item of WURSS-21 [2] Cumulative days with each item of cold like symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| [1] Cumulative score with each item of WURSS-21 [2] Cumulative score with each item of cold like symptoms [3] pDC activity (MFI of CD86, HLA-DR, CD40 and CD80) in the peripheral blood [4] The proportion of phylum and family of intestinal bacteria [5] NK activity | — |
Countries
Japan
Contacts
Public ContactRyoko Koizumi
APO PLUS STATION CO., LTD. Clinical Operations Dept., CRO Business div.
Outcome results
None listed