Effect of Topical Bromelain Versus Topical Corticosteroids in the Management of Recurrent Aphthous Stomatitis

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 2

Conditions: Recurrent Aphthous Stomatitis

Treatments: Dietary Supplement: 50% Topical Bromelain in Orabase; Dietary Supplement: 35% Topical Bromelain in Orabase; Drug: 0.1% Topical Triamcinolone Acetonide in Orabase

Study type: Interventional

Funder types: Other

Identifiers

NCT06993337

OMED 372

Details and patient eligibility

About

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.

Enrollment: 63 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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63 participants in 3 patient groups

35% Topical Bromelain in Orabase

Experimental group

Description:

Participants in this group will receive 35% bromelain gel incorporated into an orabase adhesive medium.

Treatment:

Dietary Supplement: 35% Topical Bromelain in Orabase

50% Topical Bromelain in Orabase

Experimental group

Description:

Participants assigned to this group will be treated with 50% bromelain gel formulated in orabase.

Treatment:

Dietary Supplement: 50% Topical Bromelain in Orabase

0.1% Topical Triamcinolone Acetonide in Orabase

Active Comparator group

Description:

This group will receive the standard treatment of 0.1% triamcinolone acetonide in orabase, commonly used for managing Recurrent Aphthous Stomatitis.

Treatment:

Drug: 0.1% Topical Triamcinolone Acetonide in Orabase