Antifungal Potential of Moringa Olifera-loaded Nanoparticles Against Otomycosis; Preparation, Characterization, and Clinical Evaluation
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Identification of different microorganisms infected ear
研究概览
简要总结
patients with Otomycosis were recognized by an ENT specialist. 20 patients were distributed randomly into two groups. The first group will be treated with Nystatin ear drops twice daily. The second group will be treated with Moringa ear drops. patients will be examined endoscopically by the ENT specialist. patient's swabs will be isolated and analyzed by ELISA.
详细描述
Inclusion criteria:
(1) Otomycosis .
Exclusion criteria:
- tympanic membrane perforation;
- concurrent immune suppression,
- and concurrent bacterial infection.
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ear inflammation
排除标准
- •tympanic membrane perforation
- •concurrent immune suppression,
- •concurrent bacterial infection.
研究组 & 干预措施
Placebo group
Nystatin ear drops formulations prepared as intervention except for the addition of Moringa prepared using biodegradable polymers in aseptic condition and tested for sensitivity
干预措施: Ear Drop (Drug)
Moringa group
Moringa ear drops prepared using biodegradable polymers in aseptic condition and tested for sensitivity
干预措施: Moringa oleifera leaf 10mg/100ml (Drug)
结局指标
主要结局
Identification of different microorganisms infected ear
时间窗: up to 1 month
Patients swabs (microorganisms concentration)
Number of participants recovered with clear endoscopic examination
时间窗: one week
Number of participants recovered with clear endoscopic examination
次要结局
未报告次要终点
研究者
Soad Ali
principle investigator
Deraya University