A verification study of improving on allergy-like symptoms to impacts on daily life with consumption of the test food containing fermented black jabara (Citrus jabara) in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000033708
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who are diagnosed with pollen allergy 4. Subjects who are diagnosed with allergic rhinitis 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who could have an allergy to raw materials of the test food, or possible to have serious allergic reactions to other foods and/or medicines 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 10. Subjects who are judged as ineligible to participate in the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Japanese rhino-conjunctivitis quality of life questionnaire (JRQLQ No1) * Assess the items at screening (before consumption) and 4 weeks after consumption.
- Secondary Outcome Measures
Name Time Method 1. Questionnaire based on practical guideline for the management of allergic rhinitis in Japan (record in the diary report) sneezing, runny nose, blocked nose, itchy eyes, and watery eyes 2. Specific IgE (Dermatophagoides pteronyssinus, animal dander, Japanese red-cedar, orchard grass, timothy grass, ragweed, and moth) 3. Eosinophils in the nasal discharge *1 Record the daily report every day from 1 week before starting consumption. *2, 3 Assess the items at screening (before consumption) and 4 weeks after consumption.