Effects of consumption of the test food on allergic reaction of eyes and nose in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000049377
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 44
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method