Comparing the Therapy of Otomycosis Using Clotrimazole Cream versus Clotrimazole Ear Drops: A RANDOMIZED CONTROLLED CLINICAL TRIAL
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Clinical cure will be assessed through otoscopic examination and symptom evaluation, including the resolution of ear itching, discharge, and redness. Measurements will be taken at baseline and after 4 weeks of treatment.
研究概览
简要总结
Recruitment Status SummaryStudy Title- Clotrimazole Cream versus Ear Drops for Otomycosis - A RANDOMIZED TRIAL
**Background-**Otomycosis, a fungal infection of the ear canal, is commonly treated with antifungal agents. Clotrimazole is a well-established treatment for this condition, available in various forms, including creams and ear drops. Despite its effectiveness, the optimal formulation for treating otomycosis has not been definitively established. Creams are typically used for skin infections, while ear drops are designed for ear canal application.
Purpose of Trial- This randomized controlled clinical trial was done to compare the efficacy and safety of clotrimazole cream versus clotrimazole ear drops in treating otomycosis. By evaluating both treatments head-to-head, the trial determined that clotrimazole cream is more effective than ear drops in treating uncomplicated otomycosis. Its occlusive application and higher compliance may contribute to superior clinical outcomes.
**Date-**02/06/2025] Principal Investigator- DR. SYED MOHD AHMAD Institution- HIND INSTITUTE OF MEDICAL SCIENCES
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis: Confirmed otomycosis with positive fungal culture or microscopy.
- •Age: Adults aged 18 years to 50 years.
- •Symptom Duration: Symptoms present for at least [duration, e.g., 2 weeks].
- •Ear Condition: Active otomycosis with itching, discharge, and/or pain.
- •Compliance: Ability to adhere to the treatment protocol.
- •Informed Consent: Written informed consent obtained.
- •Contraindications: No known hypersensitivity to clotrimazole.
- •General Health: Overall good health with no severe concurrent ear conditions.
- •Antifungal Treatments: No recent use of other antifungal treatments within [duration, e.g., 4 weeks].
排除标准
- •Non-Fungal Ear Infections: Diagnosis of other ear infections or significant ear pathologies.
- •Hypersensitivity: Known allergy to clotrimazole or its components.
- •Concurrent Antifungal Therapy: Recent use of other antifungal treatments.
- •Immunocompromised Conditions: Conditions affecting immune function.
- •Recent Ear Surgery: Recent ear surgery or trauma.
- •Pregnancy and Breastfeeding: Pregnant or breastfeeding women.
- •Severe Medical Conditions: Severe or uncontrolled medical conditions.
- •Inability to Follow Protocol: Inability to comply with treatment and follow-up.
- •Concurrent Participation in Another Study: Participation in other studies that may interfere.
- •Other Contraindications: Any other factors posing risk or affecting study results.
结局指标
主要结局
Clinical cure will be assessed through otoscopic examination and symptom evaluation, including the resolution of ear itching, discharge, and redness. Measurements will be taken at baseline and after 4 weeks of treatment.
时间窗: 1 week
次要结局
- Reduction in fungal load.(Improvement in patient-reported symptoms.)
研究者
Syed Mohd Ahmad
Hind Institute of medical sciences