Health Condition 1: null- Treament of Visceral Leishmaniasis
Conditions
Interventions
Intervention1: Combination therapy (Group B): Liposomal Amphotericin B single dose (FUNGISOME TM single dose of 7.5 mg / Kg body weight infused in normal saline at a rate of 100mg/100 ml/hour) follow
Sponsors
Dr Rama Prosad Goswami
Lifecare Innovations Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: HIV positive individuals, Infant and children with body weight 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Drug related adverse effects (Common Terminology Criteria for Adverse Events version 3.0)Timepoint: Throughout treatement duration and at six months | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical : fever , Spleen size, Anaemia, appetite, Body weight 2. Parasitological : Spleen/ Bone marrow smearTimepoint: 1. Clinical : end of treatment, at 6 months of follow - up and 2 - 4 years of follow up 2. Parasitological: End of treatment, at 6 months | — |
Countries
India
Contacts
Public ContactSukhen Das
School of Tropical Medicine, Kolkata, India
Outcome results
None listed