Comparative Efficacy of Topical Clotrimazole Versus 2% Salicylic Acid in Otomycosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Resolution of ear blockage
研究概览
简要总结
Otomycosis is a fungal infection of the outer ear canal that commonly causes itching, discomfort, discharge, and a feeling of blockage in the ear. This randomized controlled study was conducted to compare two commonly used topical treatments for otomycosis: clotrimazole ear drops and 2% salicylic acid ear drops. A total of 60 patients diagnosed with otomycosis were enrolled and were randomly assigned in equal numbers to one of the two treatment groups. One group received clotrimazole drops three times daily for two weeks, while the other group received 2% salicylic acid drops at the same frequency and for the same duration. Patients were assessed at the start of treatment and again after two weeks. The main outcome measure was relief of ear blockage, which reflected improvement in canal patency after treatment. It was hypothesized that topical clotrimazole would be more effective than 2% salicylic acid in clearing ear blockage and improving short-term clinical recovery in patients with otomycosis. This study was conducted to provide evidence for selecting an effective, practical, and affordable topical treatment for routine clinical use.
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
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 60 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders
- •Age 5 to 60 years
- •Patients having confirmed diagnosis of otomycosis
排除标准
- •Chronic suppurative otitis media
- •Other ear pathologies
- •Immunodeficiency
- •Diabetes mellitus
- •Receiving steroids
- •Receiving chemotherapy
- •Receiving radiotherapy
研究组 & 干预措施
Group B 2% Salicylic Acid
Received three drops of 2% salicylic acid in the affected ear three times daily for two weeks.
干预措施: 2% Salicylic Acid (Drug)
Group A Clotrimazole
Received three drops of clotrimazole in the affected ear three times daily for two weeks.
干预措施: clotrimazole (Drug)
结局指标
主要结局
Resolution of ear blockage
时间窗: 2 weeks after initiation of treatment.
Ear blockage was assessed clinically as present or absent in the affected ear. The primary outcome measure was the proportion of patients who achieved absence of ear blockage after treatment, reflecting restoration of external auditory canal patency. The assessment was performed by the same ENT consultant in both treatment groups.
次要结局
- Clearance of fungal debris(2 weeks after initiation of treatment.)
研究者
Adeel Ahmed
Principal Investigator
Mayo Hospital Lahore
