A verification study of improving on the oral cavity environment of the test food: an open-label trial

Not Applicable

• Conditions: Healthy Japanese subjects

• Registration Number: JPRN-UMIN000035393
• Lead Sponsor: ORTHOMEDICO Inc.

Brief Summary

Morinaga H, Tanaka M. HGH Crystal MD(R) Improves the Oral Environment-An Open-label,Observational Before-after Study-. Jpn Pharmacol Ther. 2019; 47(8): 1297-1313.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-28
• Study Completion: 2019-03-29
• Results First Posted: 2019-08-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction. 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD). 3. 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. 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily. 5. Subjects who are currently taking medications (including herbal medicines) and dietary supplements. 6. Subjects who are identified at least severe tooth decay by dentist. 7. Subjects who use implants, tooth caps, dentures, and bridges. 8. Subjects who have received treatment of periodontosis or with antimicrobial drugs (including antibacterial drugs) within the last three months. 9. Subjects who have received dental maintenance care, such as removing dental plaques and dental tartars within the last three months. 10. Subjects who are under treatment or diagnosed with any of dental diseases. 11. Subjects who regularly use floss, interdental cleaner, and mouthwash. 12. Subjects who are allergic to medicines and/or the test food related products. 13. Subjects who are pregnant, breast-feeding, or planning to become pregnant. 14. Subjects who 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. 15. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified