A comparative study of effect of oral itraconazole and terbinafine in tinea infection with species identification of dermatophtyes isolated from superficial fungal infections at tertiary care centre

Mahatma Gandhi Hospital1 个研究点分布在 1 个国家目标入组 96 人开始时间: 2023年10月27日最近更新: 2023年10月17日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 96
试验地点: 1
主要终点: By assessing dercrease in erythema, scaling, vesiculation, fissuring, maceration, exudation

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

patient will be recruited of tinea infection accroding to inclusion and exclusion criteria and primary outcome will be measured. In this study, efficacy of 130mg SB dose and 200mg dose of itraconazole given once a day and terbinafine 250mg and 500mg given once a day for 6 weeks will be compared. Also the species commonly found in tinea infection and drug and dose most effective against them will be identified.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•all KOH positive tinea cases of age between 18 and 65 years -body surface area involvement more than 5% -patient giving written informed consent for study.

排除标准

•pregnant and lactating women -patient with preexisting renal, hepatic and cardiac disease -patient with onychomycosis.

结局指标

主要结局

By assessing dercrease in erythema, scaling, vesiculation, fissuring, maceration, exudation

时间窗: baseline, 3 weeks, 6 weeks and 12 weeks

次要结局

to know about relapse(at 3 months follow up)

研究者

发起方

Mahatma Gandhi Hospital

申办方类型

Private medical college

研究点 (1)

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