Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis

Al-Azhar University

Status and phase: Completed; Early Phase 1

Conditions: ORAS; Oral Mucositis; Oral Ulcer; Oral Infection

Treatments: Combination Product: Combination of diclofenac potassium and propolis; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05413096

oral Aphthosis 650/3607

Details and patient eligibility

About

The combination of diclofenac and propolis could enhance the healing of recurrent aphthous ulcers, instantly relieve symptoms, improve the quality of life, and present a de novo and cost-effective regime help in oral ulcer treatment. This study aimed to evaluate the influence of diclofenac and propolis combination as a gel in the treatment of recurrent oral ulceration

Enrollment: 100 patients

Sex: All

Ages: 5 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients have an oral mucosal ulcer

Exclusion criteria

• patients allergic to any component of the diclofenac formulation and other NSAIDs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

placebo tube

Placebo Comparator group

Description:

neutral material without any biological effects

Treatment:

Other: placebo

Combination of diclofenac potassium and propolis

Active Comparator group

Description:

active agents combination of diclofenac potassium 3% (10 mg/g, 60 g, EMS) and Propolis 5% gel

Treatment:

Combination Product: Combination of diclofenac potassium and propolis