Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Recurrent Aphthous Stomatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 35% Topical Bromelain in Orabase, 50% Topical Bromelain in Orabase, 0.1% Topical Triamcinolone Acetonide in Orabase.
- Who it may be relevant to
- Registry conditions: Recurrent Aphthous Stomatitis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Topical Bromelain Versus Topical Corticosteroids in Management of Recurrent Aphthous Stomatitis: A Randomized Controlled Trial
Overview
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.
Interventions
- Dietary supplement 35% Topical Bromelain in Orabase
Bromelain 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. - Dietary supplement 50% Topical Bromelain in Orabase
Bromelain 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. - Drug 0.1% Topical Triamcinolone Acetonide in Orabase
Triamcinolone 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
Primary outcome measures
- Pain associated with ulcers [Time frame: Recorded at baseline, day 2, day 4 and day 7]
Secondary outcome measures (4)
- Reduction in ulcer size [Time frame: Recorded at baseline, day 2, day 4 and day 7]
- Number of oral ulcers [Time frame: Recorded at baseline, day 2, day 4 and day 7]
- Healing time of oral ulcer [Time frame: Recorded at baseline, day 2, day 4 and day 7]
- Oral ulcer activity index [Time frame: Recorded at baseline, day 2, day 4 and day 7]
Eligibility criteria
Inclusion criteria
- Adults aged 18-60 years.
- Diagnosed with RAS.
- Onset of ulcer within the last 48 hours.
- Willingness to participate and provide informed consent.
Exclusion criteria
- History of hematological deficiencies, GIT disorders, Behcet's disease and major systemic diseases.
- Pregnant or breastfeeding patients.
- Previous treatment for the current ulcer episode.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06993337 · OMED 372