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

Early Phase 1

Completed

• Conditions: Oral Mucositis; Oral Infection; Oral Ulcer; ORAS
• Interventions: Other: placebo; Combination Product: Combination of diclofenac potassium and propolis

• Registration Number: NCT05413096
• Lead Sponsor: Al-Azhar University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-09
• Primary Completion: 2022-10-01
• Study Completion: 2022-11-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients have an oral mucosal ulcer

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo tube	placebo	neutral material without any biological effects
Combination of diclofenac potassium and propolis	Combination of diclofenac potassium and propolis	active agents combination of diclofenac potassium 3% (10 mg/g, 60 g, EMS) and Propolis 5% gel

Primary Outcome Measures

Name	Time	Method
chronic oral mucosal disease questionnaire	10 days	patient response

Secondary Outcome Measures

Name	Time	Method
ulcer characters	10 days	size

Trial Locations

Locations (1)

Al Azhar university; 🇪🇬 Cairo, Egypt