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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-15

Study Completion Date

2026-06-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Recurrent Aphthous Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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35% Topical Bromelain in Orabase

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

Group Type EXPERIMENTAL

35% Topical Bromelain in Orabase

Intervention Type DIETARY_SUPPLEMENT

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.

50% Topical Bromelain in Orabase

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

Group Type EXPERIMENTAL

50% Topical Bromelain in Orabase

Intervention Type DIETARY_SUPPLEMENT

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.

0.1% Topical Triamcinolone Acetonide in Orabase

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

Group Type ACTIVE_COMPARATOR

0.1% Topical Triamcinolone Acetonide in Orabase

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No