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临床试验/CTRI/2018/05/014015
CTRI/2018/05/014015进行中(未招募)3 期

Assessment of Safety,efficacy of Liposomal Amphotericin B (AmBisome) Vs Miltefosine 12 weeks therapy in patients with Post Kala-Azar Dermal Leishmaniasis (PKDL)-an observational pilot study

RAJENDRA MEMORIAL RESEARCH INSTITUTE OF MEDICAL SCIENCES0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
进行中(未招募)

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 or female patients aged 5- 65 years
  • Macules, nodules and papules or plaques as clinical signs consistent with post Kala-azar dermal Leishmaniasis.
  • Post kala azar dermal leishmaniasis (PKDL), parasitologically confirmed (amastigotes in slit-skin or snip skin smears and/or skin biopsies and qPCR)

排除标准

  • Pregnant and lactating female
  • Patients not willing to participate.
  • Thrombocyte count <100 x 1000000000/l
  • Leukocyte count <2.5 x 1000000000/l
  • Hemoglobin < 8.0 g/100 ml
  • ASAT, ALAT, AP >3 times upper limit of normal range
  • Bilirubin >2 times upper limit of normal range
  • HbsAg, HCV and HIV positive
  • Serum creatinine or BUN >1.5 times upper limit of normal range
  • Hypersensitivity to AmBisome or inactive ingredients of AmBisome and Miltefosine.
  • Patients not willing to take contraceptive measures during study duration.

研究者

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