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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2023-07-27

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.

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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.

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Conditions

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Oral Thrush

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 parallel arms

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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interventional

chitosan loaded with miconazole nanoparticles gel

Group Type EXPERIMENTAL

Chitosan

Intervention Type DRUG

chitosan loaded with miconazole nanoparticles gel

control

miconazole gel

Group Type EXPERIMENTAL

Chitosan

Intervention Type DRUG

chitosan loaded with miconazole nanoparticles gel

Interventions

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Chitosan

chitosan loaded with miconazole nanoparticles gel

Intervention Type DRUG

Other Intervention Names

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miconaz oral gel

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No