NCT07295210已完成不适用
Boric Acid Versus 10% Povidone Iodine Solution in Treatment of Otomycosis: a Randomized Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- objective clinical response
研究概览
简要总结
This study compares two topical agents for the treatment of fungal infection of the external auditory canal: boric acid and a 10% povidone-iodine solution
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all consecutive patients with otomycosis, recruited from the outpatient clinic during the study duration
排除标准
- •tympanic membrane perforation
- •previous ear surgery
- •significant medical co-morbidities such as poorly controlled diabetes or immunocompromised patients
- •patient refusal to participate in the study
研究组 & 干预措施
Boric acid group
Active Comparator
干预措施: Boric acid (Drug)
Povidone iodine group
Active Comparator
干预措施: Povidone iodine 10% (Drug)
结局指标
主要结局
objective clinical response
时间窗: Days 7, 14, and 28 after treatment
clinical response is assessed by ear examination by presence or absence of fungal hyphae inside the external auditory canal
Microbiological response
时间窗: day 28 after treatment
Microbiological response is evaluated by obtaining cultures from the external auditory canal searching for fungal growth
次要结局
- subjective pain response(days 7, 14, and 28 after treatment)
- subjective itching response(days 7, 14, and 28 after treatment)
研究者
研究点 (1)
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