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Clinical trial

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

ID
Name
oral Aphthosis 650/3607
Description
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
Trial arms
Trial start
2021-06-01
Estimated PCD
2022-10-01
Trial end
2022-11-01
Status
Completed
Phase
Early phase I
Treatment
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
Arms:
Combination of diclofenac potassium and propolis
placebo
placebo
Arms:
placebo tube
Size
100
Primary endpoint
chronic oral mucosal disease questionnaire
10 days
Eligibility criteria
Inclusion Criteria: * patients have an oral mucosal ulcer Exclusion Criteria: * patients allergic to any component of the diclofenac formulation and other NSAIDs
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized clinical, double-blind, placebo-controlled study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'caregiver and participants and investigator are masked', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2023-07-21

1 organization

1 product

4 indications

Organization
Al-Azhar University
Product
Diclofenac potassium + Propolis
Indication
Oral Mucositis
Indication
Orofacial Renal Syndrome
Indication
Oral Infection
Indication
Oral Ulcer