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

NCT05413096 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-07-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-10-01
Completion
2022-11-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05413096 on ClinicalTrials.gov