NCT05413096

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 5 Years – 70 Years
• Healthy volunteers: Accepted

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

Conditions

• Oral Mucositis
• ORAS
• Oral Infection
• Oral Ulcer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-10-01
• Completion: 2022-11-01
• First posted: 2022-06-09
• Last updated: 2023-07-21

Locations

1 site across 1 country: Egypt