NCT06622213

Mucoadhesive Film With/without Acmella Oleracea & Triamcinolone Acetonide for Aphthous Ulcers

Comparison of the Efficacy of Mucoadhesive Film with and Without Acmella Oleracea Extract and 0.1% Triamcinolone Acetonide for Treatment of Aphthous Ulcers: a Randomized Control Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effectiveness of mucoadhesive film with or without Acmella oleracea extract compared to standard treatment by using 0.1% triamcinolone acetonide in pain relief, promoting wound healing, healing time and satisfaction in 3 aspects included taste, product used and quality of life after using the product.

Detailed description

Participants who consent and meet the inclusion criteria will be allocated into 3 groups using block randomization: group 1: mucoadhesive film with Acmella oleracea extract, group 2: 0.1% triamcinolone acetonide, and group 3: mucoadhesive film without Acmella oleracea extract.

Conditions

• Aphthous Stomatitis

Interventions

Type	Name	Description
OTHER	mucoadhesive film with Acmella oleracea extract	Apply 1 patch on ulcer 3 times per day (after meals)
DRUG	Triamcinolone Acetonide 0.1% Oromucosal Paste	Apply ¼ inch on ulcer 3 times per day (after meals)
OTHER	mucoadhesive film without Acmella oleracea extract	Apply 1 patch on ulcer 3 times per day (after meals)

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-05-01
• Completion: 2026-05-01
• First posted: 2024-10-02
• Last updated: 2024-10-02