Effectiveness of 4% Boric Acid in Distilled Water Versus Clotrimazole Solution in Otomycosis Patients.
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
- 否
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
randomized 50 otomycosis patients will receive Clotrimazol solution 1%
干预措施: Clotrimazol solution 1% (Drug)
group 2
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
Maria Hosny Kamal Gendi
resident doctor
Assiut University
