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OpenTrials
Completed

NCT Number: NCT06072716

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

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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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

radwa Elsherif

Giza, Egypt

About this study

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.

.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chitosan

Drug

chitosan loaded with miconazole nanoparticles gel

Other names: miconaz oral gel

Primary outcomes

  1. clinical assessment of erythematous/psuedomembranous oral candidiasis resolution

    Time frame: 28 days

    by Pain analogue scale

Secondary outcomes

  1. microbiological count of candida

    Time frame: 28 days

    candidal count by taking swap

Sponsors and collaborators

Lead sponsor

Yasmine gamil

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 10, 2023
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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