About this trial
Bromelain, a natural product, exhibits anti-inflammatory, immunomodulatory, and wound-healing properties. However, its efficacy in treating oral mucosal ulcers remains unexplored. This study aims to evaluate the effect of bromelain as a safe alternate for management of RAS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-60 years.
Diagnosed with RAS.
Onset of ulcer within the last 48 hours.
Willingness to participate and provide informed consent.
Disqualifiers
History of hematological deficiencies, GIT disorders, Behcet's disease and major systemic diseases.
Pregnant or breastfeeding patients.
Previous treatment for the current ulcer episode.
Trial design
Parallel
Treatments tested in this trial
35% Topical Bromelain in Orabase
Dietary supplementBromelain is a natural proteolytic enzyme derived from pineapple, recognized for its broad range of pharmacological properties. It exhibits significant anti-inflammatory effects by reducing edema. In addition to its anti-inflammatory activity, bromelain possesses antioxidant and analgesic properties.
50% Topical Bromelain in Orabase
Dietary supplementBromelain is a natural proteolytic enzyme derived from pineapple, recognized for its broad range of pharmacological properties. It exhibits significant anti-inflammatory effects by reducing edema. In addition to its anti-inflammatory activity, bromelain possesses antioxidant and analgesic properties.
0.1% Topical Triamcinolone Acetonide in Orabase
DrugTriamcinolone acetonide in orabase, a corticosteroid-based standard treatment for Recurrent Aphthous Stomatitis (RAS), is used for its strong anti-inflammatory and immunosuppressive effects. In this study, it serves as the conventional treatment against the novel therapy
Treatment groups
Trial outcomes
Primary outcomes
Pain associated with ulcers
Pain reduction will be measured using a visual analog scale (VAS). VAS is a self-reported pain scores ranging from 0 to 10
Secondary outcomes
Reduction in ulcer size
The reduction in ulcer size will be assessed using periodontal probe to measure dimensions in millimeters (mm)
Number of oral ulcers
Healing time of oral ulcer
The time to complete healing will be determined by the number of days until the ulcer is no longer visible upon clinical examination
Oral ulcer activity index
Oral ulcer activity index will be measured by Composite index (CI). CI score (0-10) is calculated by summing of subscale scores of oral ulcer activity (0 vs 1), oral ulcer-related pain status evaluated by categorized VAS (0-5) and the mean global functional disability score evaluated by 5-point Likert-type scale (0-4)
Locations
Sponsors and contacts
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