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临床试验/CTRI/2016/08/007190
CTRI/2016/08/007190进行中(未招募)未知

Combination chemotherapy against visceral leishmaniasis: Comparative evaluation between miltefosine for 4 weeks and 2 weeks miltefosine combined with single dose liposomal amphotericin B in a tertiary care centre in Kolkata

Dr Rama Prosad Goswami0 个研究点目标入组 100 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
100

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

  • Patients with corroborative clinical history (prolonged fever not responding to antimalarials or antibiotics) and physical signs (anaemia, splenomegaly, hepatomegaly) with presence of parasites (LD bodies) confirmed by examination of Giemsa stained slides of splenic or bone marrow aspirates were enrolled into the study.
  • Confirmed visceral leishmaniasis patients who are fully informed about the risk of treatment and who signed the consent form themselves or by authorised relatives in their languages , will be included in the study group

排除标准

  • HIV positive individuals, Infant and children with body weight < 10Kgs, severe concurrent illnesses, receipt of any antileishmanial drugs or antifungal drugs in the previous 45 days, pregnancy and withdrawal of contraceptive measure. Patients with known hypersensitivity to the study drugs and those with diabetes, hypertension, or tuberculosis were also excluded. All patients with known heart, liver or kidney disease were excluded from the study. patients with renal function tests (serum creatinine) outside the normal range, liver function tests (transaminases) more than three times upper limit of the normal at study entry, Jaundice (bilirubin > 2.0mg/dL), Known hepatitis B or C positive, Platelet count less than 40,000/mm3, Prothrombin time 5 seconds or greater than normal range, Total WBC < 1,000/mm3, known alcohol or other drug abuse,concomitant chronic drug treatment eg for diabetes, hypertension, TB, HIV etc, concomitant drug usage for acute infection, eg malaria, pneumonia etc within the last 7 days were excluded.

研究者

发起方
Dr Rama Prosad Goswami

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