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 population

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001921

Enrollment

124

Registered

2016-05-18

Start date

2016-06-10

Completion date

Unknown

Last updated

2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Taking tongue images using computerized tongue diagnosis system (CTS-1000) - 2 times/day (at an interval of over 30-minuate)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Agreement between the tongue diagnosis system and the assessors for evaluating tongue coating thickness	—

Secondary

Measure	Time frame
Adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactNa Yeon Ha

Kyung Hee University Hospital

angelny91@naver.com+82-2-958-9140

Outcome results