A verification study of the improvement effects of the test food on mouth dryness
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000038554
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 56
Not provided
Subjects who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are undergoing medical treatment or have a medical history of a salivary gland disorder (including sialadenitis, sialolithiasis, Sjogren's syndrome, and salivary gland tumors), or Subjects who removed a salivary gland 4. are undergoing medical treatment of autoimmune disease 5. are currently undergoing treatment for the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and/or any other chronic diseases 6. use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 7. are currently taking medicines (include herbal medicines) and supplements 8. buy more than 2 packs of 9 chewing gum sheets or 14 to 20 chewing gum a month, or eat about 40 chewing gum a month 9. are smokers 10. use implants, tooth caps, dentures, and bridges 11. have received treatment of periodontosis or with antimicrobial drugs (including antibacterial drugs) within the last three months 12. have receiving dental maintenance care, such as removing dental plaques and dental tartars within the last three months 13. are under treatment or diagnosed with any of dental diseases 14. regularly use floss, interdental cleaner, and mouthwash 15. are allergic to medicines and/or the test food related products 16. are pregnant, lactation, or planning to become pregnant 17. have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 18. 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 The amount of changes of visual analogue scale (VAS) values of subjective mouth dryness between at screening (before test-food consumption; Scr) and 8 weeks after the start of test-food consumption (8w)
- Secondary Outcome Measures
Name Time Method