Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing the pineneedle extract Administration: Take eight capsules with water before breakfast * Daily dose should be taken within the day. If you forget
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 subjective symptoms of allergic rhinitis (such as sneezing, runny nose, stuffy nose, or itchy eyes) at last two years 6. Subjects whose eyes and nose allergic reaction based on results of the background investigation questionnaire at screening (before consumption; Scr) is worse than other subjects *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, 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 take functional food/beverage that may affect allergic reaction, such as beta-carotene, methylated catechins, lactic acid bacteria, bifidobacteria, rosmarinic acid, acetic acid bacteria, soy fermented polysaccharides, caffeic acid, luteolin, quercetin, hesperidin, or nobiletin at least four times a week 6. Subjects who drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 7. Subjects who are currently taking medications (including herbal medicines) and supplements 8. 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 9. Subjects who are allergic to medicines and/or the test food related products 10. Subjects who are pregnant, lactation, or planning to become pregnant during this trial 11. Subjects who suffer from COVID-19 12. 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 13. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The score of Japanese rhino-conjunctivitis quality of life questionnaire (JRQLQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Each item of JRQLQ 2. Each item of the severity classification of allergic rhinitis 3. Non-specific immunoglobulin E (IgE), specific IgE (house dust and mite), and eosinophils in nasal discharge | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed