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

Yasmine gamil

Status and phase: Completed; Phase 1

Conditions: Oral Thrush

Treatments: Drug: Chitosan

Study type: Interventional

Funder types: Other

Identifiers

NCT06072716

Mti University

Details and patient eligibility

About

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.

Full description

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.

.

Enrollment: 80 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

interventional

Experimental group

Description:

chitosan loaded with miconazole nanoparticles gel

Treatment:

Drug: Chitosan

control

Experimental group

Description:

miconazole gel

Treatment:

Drug: Chitosan