Oral ThrushPhase 1NCT06072716
The Anti-fungal Effect of Miconazol Versus Miconazol-Loaded Chitosan Nanoparticles
A Phase 1 study testing Chitosan in people with Oral Thrush, run by Yasmine gamil at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Oral Thrush
- What is being tested?
- Chitosan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2023to 27 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
.
- Conditions
- Oral Thrush
- Being tested
- Chitosan
- Keywords
- diabetic patients or oral candidiasis or oral thrush
- Medical subject headings
- Candidiasis, Candidiasis, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChitosanDrug
Also called miconaz oral gel
chitosan loaded with miconazole nanoparticles gel
| Study group | Role | What they receive |
|---|---|---|
| interventional | Experimental | chitosan loaded with miconazole nanoparticles gel Receives: Drug: Chitosan |
| control | Experimental | miconazole gel Receives: Drug: Chitosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical assessment of erythematous/psuedomembranous oral candidiasis resolution
by Pain analogue scale
Measured: 28 days
Secondary outcomes (1)
microbiological count of candida
candidal count by taking swap
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start10 Jan 2023
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral ThrushStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 parallel arms
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasmine gamil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasmine gamil, MTI University
- Investigators
- radwa ELsherif, PHD, Principal investigator, MUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072716
- Sponsor's protocol ID
- Mti University
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38321454
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06072716
- Acronym / sponsor ID
- Mti University
- Conditions
- Oral Thrush
- Keywords
- diabetic patients or oral candidiasis or oral thrush
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yasmine gamilUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 parallel arms
| Arm | Type | Receives |
|---|---|---|
| interventional | Experimental | Drug: Chitosanchitosan loaded with miconazole nanoparticles gel |
| control | Experimental | Drug: Chitosanmiconazole gel |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChitosanAlso: miconaz oral gelchitosan loaded with miconazole nanoparticles gel | Drug | control, interventional |
Primary outcome
clinical assessment of erythematous/psuedomembranous oral candidiasis resolution
Time frame: 28 days
by Pain analogue scale
1 secondary outcome
microbiological count of candida
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 38321454Gamil 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
radwa ELsherif, PHD principal investigator
MUST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chitosan in people with Oral Thrush, run by Yasmine gamil at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical assessment of erythematous/psuedomembranous oral candidiasis resolution (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06072716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.