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

NCT05413096 | Completed Early Phase 1

• 1 other identifier: oral Aphthosis 650/3607
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diclofenac; oral disease; oral Aphthosis; propolis

Outcome Measures

Primary Outcomes (1)

• chronic oral mucosal disease questionnaire

  patient response

  10 days

Secondary Outcomes (1)

• ulcer characters

  10 days

Study Arms (2)

placebo tube

PLACEBO COMPARATOR

neutral material without any biological effects

Other: placebo

Combination of diclofenac potassium and propolis

ACTIVE COMPARATOR

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

Combination Product: Combination of diclofenac potassium and propolis

Interventions

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

Combination of diclofenac potassium and propolis

placebo OTHER

placebo

placebo tube

Eligibility Criteria

• Age: 5 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients have an oral mucosal ulcer

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al Azhar university

Cairo, 11825, Egypt

Location

MeSH Terms

Conditions

Stomatitis; Oral Ulcer; Mouth Diseases

Interventions

Propolis

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: caregiver and participants and investigator are masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: A randomized clinical, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 9, 2022
• Study Start: June 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months
• Access Criteria: main investigator

Locations

EG (1)