None
Conditions
Interventions
Intakes of test tablets for 12 weeks
Intakes of placebo tablets for 12 weeks
Sponsors
TES Holdings Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and Female aged from 20 to 64 years, when giving the informed consent. 2.Healthy individuals not having any chronic diseases. 3.Individuals with allergic reaction of eyes and nose in early spring. 4.Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will. 5.Individuals who can accomplish their tasks in the study at the appointed date 6.Individuals who are judged suitable for this study by the investigator.
Exclusion criteria
Exclusion criteria: Individuals 1.who have some diseases with drug therapy. 2.who sometimes or regularly use oral antiallergic drugs or will use during the test period. 3.who have history of intranasal laser therapy or sublingual immunotherapy to reduce allergic symptoms. 4.who are a patient of or have a history of asthma. 5.who are a patient of or have a history of atopic dermatitis or chronic urticaria. 6.who are a patient or have a history of mental disease, psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. 7.who consecutively receive drugs for treatment of disease in the last 1 month. 8.who could have severe allergy to foods or drugs. 9.who have severe disease histories in liver, kidney, heart, lung, blood or the other tissues. 10.who are a patient or have a history of endocrine disease. 11.whose BMI is over 30 kg/m2 12.who have donated over 200 mL of blood in the last 1 month or 400 mL of blood in the last 3 months. 13.who cannot stop to ingest intestinal drugs or supplements during the test period. 14.who had a habit to ingest health-promoting foods, health foods, or supplements containing similar composition with a test food or will ingest those foods during the test period. 15.who generally intake alcohol drinks over 60g/day as the amount of pure alcohol. 16.who could change their location and their life style during the study, e.g. business trip or traveling for a long time. 17.who are pregnant, breastfeeding, or planning to be pregnant. 18.who participated in other clinical trials in the last 3 months. 19.who and whose family work for a company manufacturing or selling healthy foods, functional foods. 20.who refuse to disclose their biological sex. 21.who are judged unsuitable for this study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| <Efficacy> The discomfort of eyes and nose in the daily life | — |
Secondary
| Measure | Time frame |
|---|---|
| <Efficacy> Evaluation of allergic rhinitis Specific measurement of blood <Safety> Blood pressure, pulse, body weight, body fat percentage, body mass index, hematology test, biochemical test, urinalysis, assessment of adverse events by a medical doctor. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd Administrative Department of Clinical Trials
Outcome results
None listed