Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis
Sponsor
Al-Azhar University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05413096
Collaborator
(none)
100
1
2
13.9
7.2
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A randomized clinical, double-blind, placebo-controlled studyA randomized clinical, double-blind, placebo-controlled study
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
caregiver and participants and investigator are masked
Primary Purpose:
Treatment
Official Title:
Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis
Actual Study Start Date
:
Jun 1, 2021
Anticipated Primary Completion Date
:
Jun 30, 2022
Anticipated Study Completion Date
:
Jul 30, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: x labeled tube neutral material without any biological effects |
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
|
| Active Comparator: Y labeled tube active agents |
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
|
Outcome Measures
Primary Outcome Measures
- chronic oral mucosal disease questionnaire [10 days]
patient response
Secondary Outcome Measures
- ulcer characters [10 days]
size ,margin
Eligibility Criteria
Criteria
Ages Eligible for Study:
5 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- patients have an oral mucosal ulcer
Exclusion Criteria:
- patients allergic to any component of the diclofenac formulation and other NSAIDs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Al Azhar university | Cairo | Egypt | 11825 |
Sponsors and Collaborators
- Al-Azhar University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mohamed Ismail Assadawy,
lecturer,
Al-Azhar University
ClinicalTrials.gov Identifier:
NCT05413096
Other Study ID Numbers:
- oral Aphthosis 650/3607
First Posted:
Jun 9, 2022
Last Update Posted:
Jun 9, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Ismail Assadawy,
lecturer,
Al-Azhar University
Additional relevant MeSH terms: