A conclusive clinical trial to investigate the safety and efficacy of computerized tongue diagnosis system (CTS-1000) on determining tongue coating thickness in the adult populatio
- Conditions
- Not Applicable
- Registration Number
- KCT0001921
- Lead Sponsor
- Daiseung Medics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 124
1. agree with participation in this study and sign a written informed consent voluntarily
2. are aged 19 years and older
3. are able to read, write or communicate
1. have a severe illness
2. are unable to stop taking medications for 1 week
3. are unable to fast for 4 hours
4. are unable to open the mouth due to temporomandibular joint disorders
5. are unable to protrude the tongue
6. have tongue motility disturbance due to stroke, glossopharyngeal nerve palsy
7. have glossitis or geographic tongue
8. have hemorrhagic disease in the oral cavity
9. have anatomical abnormality on the tongue
10. have past history of mental disorder
11. are pregnant or breastfeeding
12. may have poor health due to participation of this study
13. are taking part in the other clinical trial
14. are inappropriate at the investigator’s discretion
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Agreement between the tongue diagnosis system and the assessors for evaluating tongue coating thickness
- Secondary Outcome Measures
Name Time Method Adverse events