CTRI/2023/05/052604已完成不适用
Comparison of oral Terbinafine Vs oral Itraconazole in patients of Tinea Cruris in a tertiary care hospital of North East India- an open level randomized clinical trial
AGMC GBP Hospital1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2023年5月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Erythema, Scaling, peripheral spread to other body sites
研究概览
简要总结
Positive KOH Tinea cruris patients will be randomized and recruited into two groups and oral Terbinafine 500 mg and oral Itraconazole 100 mg will be given for 14 days. The purpose of the study is to compare the safety and efficiency of Terbinafine and Itraconazole. For that purpose LFT will be 0 and 42 days and KOH will be done at 0, 14 and 42 days of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
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 NEWLY DIAGNOSED TINEA CRURIS SUBJECTS HAVE NOT RECEIVED ANTIFUNGAL IN LAST 14 DAYS.
排除标准
- •PREGNANT AND LACTATING WOMEN PATIENTS ON IMMUNOSUPPRESSIVE DRUGS PATIENTS UNWILLING FOR A REGULAR FOLLOW UP PATIENTS WITH RELAPSE AND RECURRENT CASES OF TINEA CRURIS.
结局指标
主要结局
Erythema, Scaling, peripheral spread to other body sites
时间窗: After 14 days and 42 days of treatment
次要结局
- LFT(42 DAYS)
研究者
研究点 (1)
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