Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Plant A oil Administration: Take two packets (4.4 g/packet x two packets, in total 8.8 g) at any time during the day *Take the test food in however preferred (as it
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects who have eyes and nose discomfort by pollen at last two years 6. Subjects who receive a comprehensive explanation of this study, can understand it, and provide a written informed consent 7. Subjects who do not use antiallergic drugs at the agreement to participate in this trial 8. Subjects whose total score of JRQLQ is bad at screening (before consumption: Scr) *Among the healthy subjects and those with mild symptoms, more than half of the enrolled subjects will be selected from healthy subjects. (i) Healthy subjects who have eyes and nose discomfort by pollen at last two years and do not use antiallergic drugs (ii) Subjects with mild symptoms who have eyes and nose discomfort by pollen at last two years and sometimes (not regularly) use antiallergic drugs *"Sometimes" means using a drug as needed. *"Regularly use" means using a drug at fixed intervals even if there are no symptoms.
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, hemorrhagic disease, intestinal disorder, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products (particularly, plant A, plant A oil, plant B, or plant B oil) 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. Subjects who suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in this study by the physician 11. Subjects who are receiving long-term drug treatment (antiallergic drugs, antihistamines, steroids, vasoconstrictors, antihypertensives, etc.) that may affect allergic symptoms of the nose and eyes during the trial 12. Subjects who have a nasal irrigation habit 13. Subjects who do not go out more than once a week 14. Subjects whose eating habit is extremely irregular 15. Subjects whose life rhythms are irregular due to shift work, night work, or others 16. Subjects who plan to undergo surgery between two weeks prior to the test food consumption and two weeks posterior to completion of consumption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The total score of Japanese rhino-conjunctivitis quality of life questionnaire (JRQLQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Each score (except for the total score) and each survey item of JRQLQ 2. Sneezing, runny nose, blocked nose, impacts on daily life, itchy eyes, and watery eyes 3. The number of eosinophils in nasal discharge, non-specific immunoglobulin E (IgE), and specific IgE (Four types: Japanese red-cedar, cypress, Dermatophagoides pteronyssinus, and house dust) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed