Back to resultsCombination 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
About this trial
This is an interventional treatment trial for Oral Mucositis focused on measuring diclofenac, oral disease, oral Aphthosis, propolis
Eligibility Criteria
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
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
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