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临床试验/NCT04824261
NCT04824261Unknown不适用

Effectiveness of 4% Boric Acid in Distilled Water Versus Clotrimazole Solution in Otomycosis Patients.

Assiut University0 个研究点目标入组 100 人开始时间: 2021年6月1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
入组人数
100
主要终点
Curative rate of otomycosis

研究概览

简要总结

Otomycosis is a fungal infection that affects one, or occasionally both, of the ears. It mostly affects people who live in warm or tropical areas. It also often affects people who swim frequently, live with diabetes, or have other chronic medical and skin conditions. It is a pathologic entity, with candida and aspergillus the most common fungal species. ]Various predisposing factors include a humid climate, presence of cerumen, instrumentation of the ear, increased use of topical antibiotics / steroid preparations, immune-compromised host, patients who have undergone open cavity mastoidectomy and those who wear hearing aids with occlusive ear mold. The infection is usually unilateral and characterized by inflammatory pruritis, scaling and otalgia.Treatment recommendations have included local debridement, local and systemic antifungal agents and discontinuation of topical antibiotics. Sometimes otomycosis presents as a challenging disease for its long term treatment and follow up, yet its recurrence rate remains high.

According to Thai National List of essential medicines for topical antifugal agents are:

  • acetic acid (2% in aqueous and 2% in 70% isopropyl alcohol)
  • boric acid (4% in distilled water)
  • gentian violet
  • clotrimazole ear drop. Some fungal infections such as Aspergillus may be resistant to the usual ear drops. They may require oral medications.

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

入选标准

  • Symptomatic otomycosis.
  • Microscopic direct examination and/or culture positive for fungus.

排除标准

  • During usage of systemic antifungal drug
  • Allergic to 4% boric acid in distilled water or clotrimazole solution

研究组 & 干预措施

group 1

Active Comparator

randomized 50 otomycosis patients will receive Clotrimazol solution 1%

干预措施: Clotrimazol solution 1% (Drug)

group 2

Active Comparator

randomized 50 otomycosis patients will receive 4%boric acid in distilled water

干预措施: 4%boric acid in distilled water (Drug)

结局指标

主要结局

Curative rate of otomycosis

时间窗: 1 month

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Hosny Kamal Gendi

resident doctor

Assiut University

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