Health Condition 1: null- PKDL (Post Kala-azar Dermal Leishmaniasis) Patients
Conditions
Interventions
Intervention1: Amphotericin-B: Amphotericin-B
Dose 0.5 mg/kg/body weight for 20 infusion on alternate days for three courses at 15 days intervals
Control Intervention1: Amphotericin-B: 1 mg/kg/body w
Sponsors
Intramural Projects of RMRIMS ICMR
Eligibility
Inclusion criteria
Inclusion criteria: • Both sex patients aged 5-60 years • Parasitologically confirmed Post kala azar dermal leishmaniasis (PKDL) • All types of PKDL
Exclusion criteria
Exclusion criteria: • Pregnant and lactating females. • Patients not willing to participate. • Individuals who were sero positive for HIV • Individuals with a serious concurrent infection (e.g., tuberculosis or bacterial pneumonia) were excluded from the study. • Thrombocyte count • Leukocyte count • Hemoglobin • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary out come: Initial cure rate was 92% and 88% in group A and Group B respectively. Secondary outcome: Final cure rate 88% and 84% in group A and Group B respectively. Nephrotoxicity, rigor, nausea and vomiting were found to be most frequently occurring ADRs in group B as compare to group ATimepoint: Three months for primary outcome and one year for secondary outcome | — |
Secondary
| Measure | Time frame |
|---|---|
| Final cure rate 88 % and 84 %Timepoint: one year | — |
Countries
India
Contacts
Public ContactDr Vidya Nand Rabi Das
Rajendra Memorial Research Institute of Medical Sciences (ICMR)
Outcome results
None listed