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NCT05413096 Clinical Trial

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

Oral Mucositis Clinical Trial

Official title:
Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05413096
Other study ID # oral Aphthosis 650/3607
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date June 1, 2021
Est. completion date November 1, 2022

Study information
Verified date July 2023
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 70 Years
Eligibility Inclusion Criteria: - patients have an oral mucosal ulcer Exclusion Criteria: - patients allergic to any component of the diclofenac formulation and other NSAIDs

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• Combination of diclofenac potassium and propolis
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
Other:
• placebo
placebo

Locations
Country Name City State
Egypt Al Azhar university Cairo

Sponsors (1)
Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary chronic oral mucosal disease questionnaire patient response 10 days
Secondary ulcer characters size 10 days
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