CTRI/2010/091/000299招募中2 期
Rationalization of single dose 10 mg/kg/bw and 15 mg /kg/bw as compared to 5 mg/kg/bw for four days of Liposomal Amphotericin B with special reference to efficacy and safety profile for treatment of visceral leishmaniasis in Bihar, India
ICMR0 个研究点目标入组 180 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
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
入选标准
- •Male and female of age between 08-60 years (inclusive)
- •Clinical signs and symptoms compatible with Kala-azar (e.g.. fever, splenomegaly, anaemia,
- •leucopenia)
- •Confirmed diagnosis of VL by visualization of parasites on splenic/bone marrow aspirate
- •Written informed consent from the patient/or from parent or guardian if under 18 years old
排除标准
- •Safety concerns:
- •Hemoglobin < 5 g/dl
- •White blood cell count < 1000/mm3
- •Platelets <50,000
- •Prothrombin time > 5 sec above control
- •ASAT > 3 times the upper limit of normal
- •Serum creatinine or BUN > 1.5 times the upper limit of normal
- •HIV positive serology
- •Tuberculosis
研究者
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