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

Phase 1

Completed

• Conditions: Oral Thrush
• Interventions: Drug: Chitosan

• Registration Number: NCT06072716
• Lead Sponsor: Yasmine gamil

Brief Summary

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

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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Study Timeline

• Study Start: 2023-01-10
• Primary Completion: 2023-07-27
• Study Completion: 2023-07-27
• Study First Submitted: 2023-09-21
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-03
• Last Update Submitted: 2023-10-03
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interventional	Chitosan	chitosan loaded with miconazole nanoparticles gel
control	Chitosan	miconazole gel

Primary Outcome Measures

Name	Time	Method
clinical assessment of erythematous/psuedomembranous oral candidiasis resolution	28 days	by Pain analogue scale

Secondary Outcome Measures

Name	Time	Method
microbiological count of candida	28 days	candidal count by taking swap

Trial Locations

Locations (1)

radwa Elsherif; 🇪🇬 Giza, Egypt