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

Early Phase 1CompletedNCT05413096

Al-Azhar University100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Oral Mucositis ORAS Oral Infection Oral Ulcer

Interventions

Combination of diclofenac potassium and propolisCOMBINATION_PRODUCT

Patients will be divided into two groups: the first one will be treated with a combination of diclofenac 3% (10 mg/g, 60 g, EMS) and Propolis 5% gel and the second one is placebo group. Participants will be allocated randomly. The patients will be asked to apply gel 2 times per day. The patients will be instructed, not to eat or drink for 1 h after application of the gel

placeboOTHER

placebo

Eligibility

Sex: ALLMin age: 5 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * patients have an oral mucosal ulcer Exclusion Criteria: * patients allergic to any component of the diclofenac formulation and other NSAIDs

Locations (1)

Al Azhar university

Cairo, Egypt

Outcomes

Primary Outcomes

chronic oral mucosal disease questionnaire

patient response

Time frame: 10 days

Secondary Outcomes

ulcer characters

size

Time frame: 10 days

Data from ClinicalTrials.gov

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