跳至主要内容
临床试验/NCT07535424
NCT07535424已完成不适用

Comparative Efficacy of Topical Clotrimazole Versus 2% Salicylic Acid in Otomycosis

Mayo Hospital Lahore1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月20日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Experimental

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

发起方
Mayo Hospital Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adeel Ahmed

Principal Investigator

Mayo Hospital Lahore

研究点 (1)

Loading locations...

相似试验