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

NCT06993337 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-05-28

No results posted yet for this study

Summary

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.

Conditions

  • Recurrent Aphthous Stomatitis

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2026-05-15
Completion
2026-06-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06993337 on ClinicalTrials.gov