Mucoadhesive Film With/without Acmella Oleracea & Triamcinolone Acetonide for Aphthous Ulcers (NCT06622213) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Mucoadhesive Film With/without Acmella Oleracea & Triamcinolone Acetonide for Aphthous Ulcers
72 participantsStarted 2024-10-15
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Healthy participants aged 18-50 years without any underlying diseases.
✓. Participants are voluntary and have signed the informed consent.
✓. Participants are literate.
✓. Participants can follow the treatment guidelines and follow up.
✓. Participants have one untreated oral ulcer lesion.
✓. If an ulcer is caused by a denture or orthodontic appliance, the cause must be eliminated before participation.
✓. Participants must not be currently participating in any other clinical studies about oral ulcer
Exclusion criteria
✕. Participants with allergies to herbal extracts, Acmella oleracea, or steroids.
✕. Participants with chronic underlying diseases.
✕. Participants with underlying diseases that may affect wound healing.
✕. Participants receiving anti-analgesic drug, systemic steroids, antibiotics, hormones, NSAIDS, or any drugs that affect the oral mucosa.
✕. Oral ulcer lesion larger than 10 mm or lesions resembling herpetic form of aphthous ulcers.
✕. Oral ulcers are caused by infection or associated with systemic diseases.
What they're measuring
1
Reduction of ulcer size after using product
Timeframe: Base line, day4, day7, day10 and day 14
2
Pain score
Timeframe: Base line, day4, day7, day10 and day 14