The Anti-fungal Effect of Miconazol Versus Miconazol-Loaded Chitosan Nanoparticles

Study Overview
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Brief Summary
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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.

Detailed Description
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Abstract: 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. Subjective and methods: In this randomized controlled clinical trial,. A total of 80 diabetic patients presenting with symptomatic oral candidiasis were randomly assigned into two treatment groups: miconazole and miconazole-loaded chitosan nanoparticles. The patients were treated for a duration 28days , and clinical assessments were conducted at baseline, 7, 14, 21 and 28 days. Microbiological analysis was performed to determine the Candida species and assess their susceptibility to the antifungal agents. Clinical parameters, including signs and symptoms of oral candidiasis, were also evaluated. .

Official Title
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The Anti-fungal Effect of Miconazol and Miconazol-Loaded Chitosan Nanoparticles in Diabetic Patients With Oral Candidiasis-Randomized Control Clinical Trial and Microbiological Analysis

Conditions
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Oral Thrush

Intervention / Treatment
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* Drug: Chitosan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: uncontrolled diabetes patients with oral candidiasis and their uncontrolled diabetes were confirmed by doing glycated hemoglobin test and their range is >7.0%, age ranged from 30-65 years patients were willing to participate in this study Exclusion Criteria: 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 pregnant nursing women smokers alcoholic patients were also excluded from the study. should not have a history of use of any drugs that can cause hyposalivation or broad spectrum antibiotics, within the last month.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 parallel arms
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional<br>chitosan loaded with miconazole nanoparticles gel | Drug: Chitosan<br>* chitosan loaded with miconazole nanoparticles gel<br>* Other names: miconaz oral gel;|
| Experimental: control<br>miconazole gel | Drug: Chitosan<br>* chitosan loaded with miconazole nanoparticles gel<br>* Other names: miconaz oral gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical assessment of erythematous/psuedomembranous oral candidiasis resolution | by Pain analogue scale | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiological count of candida | candidal count by taking swap | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic patients or oral candidiasis or oral thrush