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

Primary Purpose

Oral Thrush

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Chitosan
Sponsored by
Yasmine gamil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Thrush focused on measuring diabetic patients or oral candidiasis or oral thrush

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • radwa Elsherif

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

interventional

control

Arm Description

chitosan loaded with miconazole nanoparticles gel

miconazole gel

Outcomes

Primary Outcome Measures

clinical assessment of erythematous/psuedomembranous oral candidiasis resolution
by Pain analogue scale

Secondary Outcome Measures

microbiological count of candida
candidal count by taking swap

Full Information

First Posted
September 21, 2023
Last Updated
October 3, 2023
Sponsor
Yasmine gamil
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1. Study Identification

Unique Protocol Identification Number
NCT06072716
Brief Title
The Anti-fungal Effect of Miconazol Versus Miconazol-Loaded Chitosan Nanoparticles
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
July 27, 2023 (Actual)
Study Completion Date
July 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yasmine gamil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Thrush
Keywords
diabetic patients or oral candidiasis or oral thrush

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
1:1 parallel arms
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
interventional
Arm Type
Experimental
Arm Description
chitosan loaded with miconazole nanoparticles gel
Arm Title
control
Arm Type
Experimental
Arm Description
miconazole gel
Intervention Type
Drug
Intervention Name(s)
Chitosan
Other Intervention Name(s)
miconaz oral gel
Intervention Description
chitosan loaded with miconazole nanoparticles gel
Primary Outcome Measure Information:
Title
clinical assessment of erythematous/psuedomembranous oral candidiasis resolution
Description
by Pain analogue scale
Time Frame
28 days
Secondary Outcome Measure Information:
Title
microbiological count of candida
Description
candidal count by taking swap
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
radwa ELsherif, PHD
Organizational Affiliation
MUST
Official's Role
Principal Investigator
Facility Information:
Facility Name
radwa Elsherif
City
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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