Health Condition 1: null- Treament of Visceral Leishmaniasis
Conditions
Interventions
Intervention1: Infusion of the Liposomal amphotericin B study Drug): 5mg /Kg and 7.5 mg/Kg ( one day and two duration )
Control Intervention1: Infusion of the conventional Amphotericin B drug: a to
Sponsors
Dr R P Goswami School of tropical Medicine KolkataWest Beangal
lifecare Innovations Pvt Ltd for funisome only
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients of all ages and both sexes will be selected, if they have sysmptomsand signs of VL with demonstrable Leishmania parasites in splenic or bone marrow aspirate smears.2) Only local patients, who can attend the out patients department for follow up regularly at monthly intervals for 6 months, will be selected for the study.3) Confirmed local VL patients who are fully informed about the risk of treatment and who signed the constent form themsleves orby authorised relatives in their languages , will be included in the study group
Exclusion criteria
Exclusion criteria: 1) HIV - positive individual with VL2) VL patient already receiving antileshmanial drugs will be excluded from the study.3) Those who have hypersensitivity to drug or its consituents .4) Patients who have associated disease altering liver function tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 a. Clinical : fever , Body Weight , Liver size, spleen size, Anemia 1 b. Laboratory : Haematological and Biochemical 2. Parasitological : Spleen/ Bone marrow smear Timepoint: 1 a/ 1b : before discharge ( Fourth day of admission ) 1a, 1b, 2 : one month follow up ( from the date of first day of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical : Body weight ,anemia , Liver ad spleen size , Parasitic Load Laboratory : Hematological and Biochemical If there is no sign of relapse ,then final cure is declared.Timepoint: Every Month after discharge till 6th months | — |
Countries
India
Contacts
Public ContactDr Rama Prasad Goswami
Outcome results
None listed