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

Sponsor
Yasmine gamil (Other)
Overall Status
Completed
CT.gov ID
NCT06072716
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
6.5
Actual Duration (Months)
12.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1:1 parallel arms1:1 parallel arms
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jan 10, 2023
Actual Primary Completion Date :
Jul 27, 2023
Actual Study Completion Date :
Jul 27, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. clinical assessment of erythematous/psuedomembranous oral candidiasis resolution [28 days]

      by Pain analogue scale

    Secondary Outcome Measures

    1. microbiological count of candida [28 days]

      candidal count by taking swap

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 radwa Elsherif Giza Egypt

    Sponsors and Collaborators

    • Yasmine gamil

    Investigators

    • Principal Investigator: radwa ELsherif, PHD, MUST

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yasmine gamil, Lecturer of oral medicine and diagnosis, MTI University
    ClinicalTrials.gov Identifier:
    NCT06072716
    Other Study ID Numbers:
    • Mti University
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 10, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yasmine gamil, Lecturer of oral medicine and diagnosis, MTI University
    diabetic patients or oral candidiasis or oral thrush
    Additional relevant MeSH terms:
    Candidiasis, Oral
    Chitosan

    Study Results

    No Results Posted as of Oct 10, 2023