The Anti-fungal Effect of Miconazol Versus Miconazol-Load... | NCT06072716

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

NCT06072716

Sponsor

Yasmine gamil

Status

Completed

Last Update Posted

Oct 10, 2023Actual

Enrollment

80Actual

Phase

Phase 1

Conditions

Oral Thrush

Interventions

Chitosan

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2023Actual

Primary Completion Date

Jul 27, 2023Actual

Completion Date

Jul 27, 2023Actual

First Submitted Date

Sep 21, 2023

First Submission Date that Met QC Criteria

Oct 3, 2023

First Posted Date

Oct 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2023

Last Update Posted Date

Oct 10, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yasmine gamil, Lecturer of oral medicine and diagnosis, MTI UniversitySponsor-Investigator

Lead Sponsor

Yasmine gamilOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
interventional	Experimental	chitosan loaded with miconazole nanoparticles gel	Drug: Chitosan
control	Experimental	miconazole gel	Drug: Chitosan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chitosan	Drug	chitosan loaded with miconazole nanoparticles gel	control interventional

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
radwa ELsherif, PHD	MUST	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
radwa Elsherif		Giza			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38321454	Derived	Gamil Y, Hamed MG, Elsayed M, Essawy A, Medhat S, Zayed SO, Ismail RM. The anti-fungal effect of miconazole and miconazole-loaded chitosan nanoparticles gels in diabetic patients with Oral candidiasis-randomized control clinical trial and microbiological analysis. BMC Oral Health. 2024 Feb 7;24(1):196. doi: 10.1186/s12903-024-03952-0.

ID	Term
D002177	Candidiasis
D002180	Candidiasis, Oral

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections
D009059	Mouth Diseases

ID	Term
D002686	Chitin
D001704	Biopolymers
D011108	Polymers
D046911	Macromolecular Substances