IRCT138904241475N5已完成3 期
Double blind, randomized clinical trial on efficacy of combination of meglumine antimoniate (Glucantime) and topical nano-liposomal paromomycin for the treatment of anthroponotic cutaneous leishmaniasis (ACL) caused by Leishmania tropica
The Eastern Mediterranean Regional Office (EMRO) of the World Health Organization (WHO)0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 years 至 60 years（—）
- 性别
- All
入选标准
- •I) a) Parasitologically proven cases* of CL based on positive smear and/or culture; b) Otherwise healthy subjects on the basis of medical history, physical examination and results of blood test (if seemed necessary by the physician); c) Age 12-60 years; d) Willing to participate in the study and sign the informed consent (by the patient or his/her parent/guardian in case of younger than 18 years).
- •* Direct smear, culture and PCR will be done on every sample to identify the causative agent.
- •II) Exclusion criteria: a) Pregnant or lactating women; b) Duration of lesion more than 6 months; c) Number of lesions more than 4; d) Ulcer size greater than 3 cm in their largest diameter; e) History of full course of standard treatment (antimonials); f) History of allergy to Glucantime; g) Serious systemic illnesses (as judged by the physician); h) Participation in any drug trials in the last 60 days.
排除标准
- 未提供
研究者
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