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

NCT ID: NCT05413096

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Mucositis ORAS Oral Infection Oral Ulcer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized clinical, double-blind, placebo-controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
caregiver and participants and investigator are masked

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo tube

neutral material without any biological effects

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo

Combination of diclofenac potassium and propolis

active agents combination of diclofenac potassium 3% (10 mg/g, 60 g, EMS) and Propolis 5% gel

Group Type ACTIVE_COMPARATOR

Combination of diclofenac potassium and propolis

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type COMBINATION_PRODUCT

placebo

placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients have an oral mucosal ulcer

Exclusion Criteria

* patients allergic to any component of the diclofenac formulation and other NSAIDs
Minimum Eligible Age

5 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Ismail Assadawy

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Al Azhar university

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

oral Aphthosis 650/3607

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Omega-3 Hydrogel and Prevention of Oral Mucositis
NCT05214495 COMPLETED PHASE2/PHASE3