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Efficacy evaluation of a food ingredient to ocular and nasal symptoms of allergy in healthy adults -Randomized, double-blind, placebo-controlled, parallel-group study-

Efficacy evaluation of a food ingredient to ocular and nasal symptoms of allergy in healthy adults -Randomized, double-blind, placebo-controlled, parallel-group study- - Efficacy evaluation of a food ingredient to ocular and nasal symptoms of allergy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056574
Enrollment
130
Registered
2025-01-06
Start date
2025-01-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Intakes of test powder for 8 weeks Intakes of placebo powder for 8 weeks

Sponsors

TES Holdings Company, Limited
Lead Sponsor

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 use antiallergic drugs or will use during the test period. 3.with a history of treatments other than medication aimed at alleviating allergy symptoms (such as intranasal laser therapy, sublingual immunotherapy, etc.). 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 lifestyle 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

MeasureTime frame
The discomfort of eyes and nose in the daily life

Secondary

MeasureTime frame
Evaluation of allergic rhinitis Specific measurement of blood

Countries

Japan

Contacts

Public ContactRyoma Shimizu

TES Holdings Company, Limited Administrative Department of Clinical Trials

r.shimizu@tes-h.co.jp03-6801-8480

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026