CTRI/2020/08/027063尚未招募不适用
Itraconazole in the treatment of dermatophytosis : A comparison of 3 different dose regimens: A triple arm randomized control study
SOA university1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2020年8月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- KOH status
研究概览
简要总结
This study is a triple arm, open label, randomized control trial comparing the safety and efficacy of Itraconazole 100 mg vs 200 mg vs 400mg or 5 mg/kg whichever is lower in the treatment of dermatophytosis. This study will be conducted at IMS and SUM hospital, Bhubaneswar, India. The primary outcome measures will be KOH status, culture status, clinical clearance at 4th week and 6th week. The secondary outcome will be safety of the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All naive cases of dermatophytosis 2.Potassium hydroxide (KOH) positive cases 3.Treated cases but off treatment from topical/systemic antifungal for the last four weeks.
排除标准
- •1.Pregnant or lactating females.
- •2.History of diabetes.
- •3.Immunosuppressed patients.
- •4.Patient on drugs that interfere with itraconazole metabolism 5.History of hepatic and renal impairment.
- •6.Cases of congestive heart failure.
结局指标
主要结局
KOH status
时间窗: Outcome will be assessed after completion of study in june 2021.
Culture status
时间窗: Outcome will be assessed after completion of study in june 2021.
Clinical clearance
时间窗: Outcome will be assessed after completion of study in june 2021.
次要结局
- Safety profile(In terms of side effects of the drug at 4th week and 6th week)
研究者
研究点 (1)
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