The Anti-fungal Effect of Miconazol Versus Miconazol-Loaded Chitosan Nanoparticles
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2023
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2023
CompletedFirst Submitted
Initial submission to the registry
September 21, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedOctober 10, 2023
October 1, 2023
7 months
September 21, 2023
October 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical assessment of erythematous/psuedomembranous oral candidiasis resolution
by Pain analogue scale
28 days
Secondary Outcomes (1)
microbiological count of candida
28 days
Study Arms (2)
interventional
EXPERIMENTALchitosan loaded with miconazole nanoparticles gel
control
EXPERIMENTALmiconazole gel
Interventions
chitosan loaded with miconazole nanoparticles gel
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yasmine gamillead
Study Sites (1)
radwa Elsherif
Giza, Egypt
Related Publications (1)
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.
PMID: 38321454DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
radwa ELsherif, PHD
MUST
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Lecturer of oral medicine and diagnosis
Study Record Dates
First Submitted
September 21, 2023
First Posted
October 10, 2023
Study Start
January 10, 2023
Primary Completion
July 27, 2023
Study Completion
July 27, 2023
Last Updated
October 10, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share