Clinical trial
The Anti-fungal Effect of Miconazol and Miconazol-Loaded Chitosan Nanoparticles in Diabetic Patients With Oral Candidiasis-Randomized Control Clinical Trial and Microbiological Analysis
Name
Mti University
Description
Objective: this study aimed to evaluate the therapeutic effects of topical application of miconazole and miconazole-loaded chitosan nanoparticles in treatment diabetic patients with oral candidiasis.
Trial arms
Trial start
2023-01-10
Estimated PCD
2023-07-27
Trial end
2023-07-27
Status
Completed
Phase
Early phase I
Treatment
Chitosan
chitosan loaded with miconazole nanoparticles gel
Arms:
control, interventional
Other names:
miconaz oral gel
Size
80
Primary endpoint
clinical assessment of erythematous/psuedomembranous oral candidiasis resolution
28 days
Eligibility criteria
Inclusion Criteria:
1. uncontrolled diabetes patients with oral candidiasis and their uncontrolled diabetes were confirmed by doing glycated hemoglobin test and their range is \>7.0%,
2. age ranged from 30-65 years
3. patients were willing to participate in this study
Exclusion Criteria:
1. immunocompromised and patients with systemic diseases that can cause muscle weakness as Parkinson's disease, or others that can limit their cognitive functioning such as dementia
2. pregnant
3. nursing women
4. smokers
5. alcoholic patients were also excluded from the study.
6. should not have a history of use of any drugs that can cause hyposalivation or broad spectrum antibiotics, within the last month.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 parallel arms', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}
Updated at
2023-10-10
1 organization
1 product
1 indication
Organization
Yasmine GamilProduct
ChitosanIndication
Oral Candidiasis