An Early Phase 1 interventional study of Combination of diclofenac potassium and propolis and placebo in Oral Mucositis, ORAS and Oral Infection, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 5 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by Al-Azhar University · Early Phase 1, Interventional, and Treatment
Among 28 studies in Stomatitis with a site in Egypt — 11 open to participants now, 11 under way, 1 of them phase 3. Stomatitis · Egypt.
Among the 28 studies in Stomatitis with a site in Egypt, this one has the largest enrollment of the 27 interventional ones that give a count, is one of 2 that started in 2021, is one of 3 in phase 1, and was the 12th registered.
306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.
Browse Stomatitis studies →11 of the 28 studies in Stomatitis with a site in Egypt are open now. Recruiting first, the newest first:
Ain Shams University · Sites in Egypt
Ages 18+
Ain Shams University · Sites in Egypt
Ages up to 18
Mansoura University · Sites in Egypt
Ages 18–80 · Healthy volunteers
Ain Shams University · Sites in Egypt
Ages 18+
Children's Cancer Hospital Egypt 57357 · Sites in Egypt
Ages 3–14
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 46 Stomatitis studies recruiting now, 20 (43%) set no upper age limit and 22 (48%) stop at 75 or younger; 10 take children under 18; 5 take healthy volunteers.
This study: 5 Years to 70 Years · all sexes · healthy volunteers too.
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28 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 10 · Phase 3 4
First in 2010; this study’s year is marked. 2 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 100 is above the median of 60 across 276 interventional studies indexed under Stomatitis.
Median enrollment 42 across the 27 interventional studies, 90 across the 1 observational. Of the 12 that completed or were terminated, 0 (0%) have results posted.
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None of the 28 has an industry lead sponsor. The 10 most frequent:
Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Al-Azhar University has 2 studies filed under Stomatitis — fewer than ten, so there is no comparison to draw.
3 of the studies in Stomatitis with a site in Egypt that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07736495Phase 3Ain Shams UniversityProtective Role of Alpha-Lipoic Acid in Chemotherapy-Induced Mucositis | 2026-12-27 |
| NCT07890428Misr University for Science and TechnologyA Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers | 2026-11-20 |
| NCT07813923Alexandria UniversityCitrus Sinensis Peel Gel for Radiation-Induced Oral Mucositis | 2027-02-01 |
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Among the 28 studies in Stomatitis with a site in Egypt, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
neutral material without any biological effects
Other: placebo
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
Drug pages: Diclofenac · 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
placebo
chronic oral mucosal disease questionnaire
patient response
Time frame: 10 days
ulcer characters
size
Time frame: 10 days
Plan to share: Yes — individual participant data can be shared through the organization
Supporting information: Clinical study report
Time frame: 6 months
Access criteria: main investigator
No publications or documents are linked to this record.
Ran from Jun 2021 to primary completion in Oct 2022, 16 months.
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Diclofenac · Propolis