The Anti-fungal Effect of Miconazol and Miconazol-Loaded Chitosan Nanoparticles in Diabetic Patients With Oral Candidiasis-Randomized Control Clinical Trial and Microbiological Analysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- clinical assessment of erythematous/psuedomembranous oral candidiasis resolution
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •nursing women
- •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.
研究组 & 干预措施
interventional
chitosan loaded with miconazole nanoparticles gel
干预措施: Chitosan (Drug)
control
miconazole gel
干预措施: Chitosan (Drug)
结局指标
主要结局
clinical assessment of erythematous/psuedomembranous oral candidiasis resolution
时间窗: 28 days
by Pain analogue scale
次要结局
- microbiological count of candida(28 days)
研究者
Yasmine gamil
Lecturer of oral medicine and diagnosis
MTI University