search
Back to results

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

Primary Purpose

Oral Mucositis, ORAS, Oral Infection

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Combination of diclofenac potassium and propolis
placebo
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Mucositis focused on measuring diclofenac, oral disease, oral Aphthosis, propolis

Eligibility Criteria

5 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients have an oral mucosal ulcer

Exclusion Criteria:

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

Sites / Locations

  • Al Azhar university

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo tube

Combination of diclofenac potassium and propolis

Arm Description

neutral material without any biological effects

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

Outcomes

Primary Outcome Measures

chronic oral mucosal disease questionnaire
patient response

Secondary Outcome Measures

ulcer characters
size

Full Information

First Posted
June 7, 2022
Last Updated
July 20, 2023
Sponsor
Al-Azhar University
search

1. Study Identification

Unique Protocol Identification Number
NCT05413096
Brief Title
Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis
Official Title
Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis, ORAS, Oral Infection, Oral Ulcer
Keywords
diclofenac, oral disease, oral Aphthosis, propolis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
A randomized clinical, double-blind, placebo-controlled study
Masking
ParticipantCare ProviderInvestigator
Masking Description
caregiver and participants and investigator are masked
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo tube
Arm Type
Placebo Comparator
Arm Description
neutral material without any biological effects
Arm Title
Combination of diclofenac potassium and propolis
Arm Type
Active Comparator
Arm Description
active agents combination of diclofenac potassium 3% (10 mg/g, 60 g, EMS) and Propolis 5% gel
Intervention Type
Combination Product
Intervention Name(s)
Combination of diclofenac potassium and propolis
Intervention Description
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
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
chronic oral mucosal disease questionnaire
Description
patient response
Time Frame
10 days
Secondary Outcome Measure Information:
Title
ulcer characters
Description
size
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients have an oral mucosal ulcer Exclusion Criteria: patients allergic to any component of the diclofenac formulation and other NSAIDs
Facility Information:
Facility Name
Al Azhar university
City
Cairo
ZIP/Postal Code
11825
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
individual participant data can be shared through the organization
IPD Sharing Time Frame
6 months
IPD Sharing Access Criteria
main investigator

Learn more about this trial

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

We'll reach out to this number within 24 hrs