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

October 3, 2023 updated by: Yasmine gamil

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • radwa Elsherif

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: interventional
chitosan loaded with miconazole nanoparticles gel
Drug: Chitosan
chitosan loaded with miconazole nanoparticles gel
Other Names:
  • miconaz oral gel
Experimental: control
miconazole gel
Drug: Chitosan
chitosan loaded with miconazole nanoparticles gel
Other Names:
  • miconaz oral gel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yasmine gamil

Investigators

  • Principal Investigator: radwa ELsherif, PHD, MUST

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Actual)

July 27, 2023

Study Completion (Actual)

July 27, 2023

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Estimated)

October 9, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mti University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe