Healthy human volunteers Oral ulcer patch Centella asiatica L. Patch retention Preliminary safety study MADESIA
Conditions
Interventions
Participants were instructed to place the patch (MADESIA) with a diameter of 1.40 cm on the inner lower lip, pressing it gently for 3 seconds before releasing it.
Experimental Device
Oral Ulcer Patch Containing Standardized Centella asiatica Extract
Sponsors
PSU-Graduate Studies Scholarship
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years, 2. In good health, with no underlying medical conditions, 3. Non-smoker
Exclusion criteria
Exclusion criteria: 1. Currently wearing orthodontic appliances or dentures, 2. Presence of oral lesions, 3. Use of antihistamines, steroidal anti-inflammatory drugs, or NSAIDs within 2 weeks before enrollment, 4. Use of any oral ulcer patch within 2 weeks before enrollment, 5. Use of mouthwash within 2 weeks before enrollment, 6. Changing toothpaste within 2 weeks before enrollment, 7. A history of undergoing dental procedures within 2 weeks before enrollment, 8. Consumption of alcoholic beverages within 2 weeks before enrollment, 9. Known allergy to C. asiatica, A. vera, tamarind, sodium alginate, glycerin, coriander, or celery , 10. A diagnosis of xerostomia by a dentist, 11. Pregnancy or breastfeeding, 12. Inability to read and write in Thai (including numbers), 13. Concurrent participation in another research study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse events 7 days after end of the intervention frequency of adverse events,retention time 3 hours after end of the intervention retention time (minutes) | — |
Secondary
| Measure | Time frame |
|---|---|
| self-reported participant satisfaction 3 hours after end of the intervention Patient-reported outcome measure | — |
Countries
Thailand
Contacts
Public ContactSupontep Treerakanok
Prince of Songkla University
Outcome results
None listed