Oral MucositisEarly Phase 1NCT05413096
Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis
A Early Phase 1 study testing Combination of diclofenac potassium and propolis in people with Oral Mucositis and ORAS, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Mucositis, ORAS, Oral Infection
- What is being tested?
- Combination of diclofenac potassium and propolis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Nov 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients have an oral mucosal ulcer
Who cannot join
- patients allergic to any component of the diclofenac formulation and other NSAIDs
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Combination of diclofenac potassium and propolis, placebo
- Keywords
- diclofenac, oral disease, oral Aphthosis, propolis
- Medical subject headings
- Stomatitis, Oral Ulcer, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of diclofenac potassium and propolisCombination 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
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo tube | Placebo comparator | neutral material without any biological effects Receives: 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 Receives: Combination Product: Combination of diclofenac potassium and propolis |
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic oral mucosal disease questionnaire
patient response
Measured: 10 days
Secondary outcomes (1)
ulcer characters
size
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Jun 2021
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized clinical, double-blind, placebo-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ismail Assadawy, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413096
- Sponsor's protocol ID
- oral Aphthosis 650/3607
- Status last verified
- Jul 2023
- First submitted
- 7 Jun 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data can be shared through the organization
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis
- ClinicalTrials.gov ID
- NCT05413096
- Acronym / sponsor ID
- oral Aphthosis 650/3607
- Conditions
- Oral Mucositis, ORAS, Oral Infection, Oral Ulcer
- Keywords
- diclofenac, oral disease, oral Aphthosis, propolis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A randomized clinical, double-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| placebo tube | Placebo comparator | Other: placeboneutral material without any biological effects |
| Combination of diclofenac potassium and propolis | Active comparator | Combination Product: Combination of diclofenac potassium and propolisactive agents combination of diclofenac potassium 3% (10 mg/g, 60 g, EMS) and Propolis 5% gel |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients have an oral mucosal ulcer
Key exclusion criteria (1 listed)
- patients allergic to any component of the diclofenac formulation and other NSAIDs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of diclofenac potassium and propolisPatients 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 product | Combination of diclofenac potassium and propolis |
| placeboplacebo | Other | placebo tube |
Primary outcome
chronic oral mucosal disease questionnaire
Time frame: 10 days
patient response
1 secondary outcome
ulcer characters
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Individual participant dataSharing planned: Yes. individual participant data can be shared through the organization
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Combination of diclofenac potassium and propolis in people with Oral Mucositis and ORAS, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chronic oral mucosal disease questionnaire (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.