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OpenTrials
Completed

NCT Number: NCT05413096

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

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

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Key information

Conditions

Oral Mucositis Mouth Diseases ORAS Oral Infection Oral Ulcer Stomatitis Stomatognathic Diseases

Age range

5 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Al Azhar university

Cairo, 11825, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients have an oral mucosal ulcer

Exclusion criteria

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

Treatment and study plan

Combination of diclofenac potassium and propolis

Combination 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

Placebo

Other

placebo

Primary outcomes

  1. chronic oral mucosal disease questionnaire

    Time frame: 10 days

    patient response

Secondary outcomes

  1. ulcer characters

    Time frame: 10 days

    size

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2022
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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