Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- result as cure rate of otomycosis
研究概览
简要总结
Otomycosis is a superficial fungal infection of the external ear canal. Patients should be treated with cleaning fungal debris combined with topical antifungal agent. There is wide range of topical antifungal agents. However, there is still no consensus of the most effective topical antifungal agents in treatment otomycosis is still lacking.
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 (3% in isopropyl alcohol)
- gentian violet
- clotrimazole ear drop. But from literature review, there is no comparative study between boric acid and clotrimazole solution before.
Objective is to compare the clinical effectiveness and adverse events of 1% clotrimazole solution versus 3% boric acid in 70% alcohol for the treatment of otomycosis.
详细描述
The hypothesis has been formulated by H0 and Ha. H0 = 1% clotrimazole solution has clinical effectiveness not different from 3% boric acid in 70% alcohol for the treatment of otomycosis.
Ha = 1% clotrimazole solution has more clinical effectiveness than 3% boric acid in 70% alcohol for the treatment of otomycosis.
Inclusion criteria:
- Symptomatic otomycosis, age more than 7 year.
- Microscopic finding revealed fungus
- KOH smear positive for fungus
Exclusion criteria:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic otomycosis, age more than 7 year.
- •Microscopic finding revealed fungus
- •KOH smear positive for fungus
排除标准
- •Pregnancy
- •Tympanic membrane perforation and post mastoid surgery
- •Co-infection of ear e.g. severe otitis externa, severe myringitis which are needed other medications
- •Previous using topical antibiotic / steroid within 2weeks.
- •During usage of systemic antifungal drug
- •Allergic to 3% boric acid in70% alcohol or 1% clotrimazole solution.
- •Those who can not come to follow up after one week of the treatment
研究组 & 干预措施
3% boric acid
control
干预措施: 3% Boric acid (Drug)
1% clotrimazole ear drop
3% boric acid is set as control while 1% clotrimazole ear drop is set as intervention.
干预措施: clotrimazole (Drug)
结局指标
主要结局
result as cure rate of otomycosis
时间窗: 1 week after treatment
otolaryngologist's microscopic finding
次要结局
- adverse effect of treatment(Five minutes after apply treatment)
研究者
Ms. Sarisa Romsaithong
Medical physician, senior professional level
Khon Kaen Hospital