Health Condition 1: B550- Visceral leishmaniasis
Conditions
Interventions
Control Intervention1: NIL: NIL
Sponsors
Extramural project of RMRIMS ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 5-65 years 2. Post kala azar dermal leishmaniasis (PKDL), parasitologically confirmed (amastigotes in slit-skin or snip skin smears and/or skin biopsies) 3. Macules, nodules and papules or plaques as clinical signs consistent with post Kala-azar dermal Leishmaniasis
Exclusion criteria
Exclusion criteria: 1. Females not willing for contraception. 2. Patients not willing to participate. 3. Thrombocyte count 4. Leukocyte count 5. Hemoglobin 6. ASAT, ALAT, AP >3 times upper limit of normal range 7. Bilirubin >2 times upper limit of normal range 8. HbsAg, HCV and HIV positive 9. Serum creatinine or BUN >1.5 times upper limit of normal range 10. Hypersensitivity to miltefosine, paromomycin or inactive ingredients of miltefosine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mentioned sample size (448) will be collected for our studyTimepoint: Period which may be needed for collecting the samples: 8 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The diagnostic and prognostic utility of Leish-LAMP assay kits will be validated on the basis of primary outcomes subjectsTimepoint: Period which may be needed for analysis the data: 4 months | — |
Countries
India
Contacts
Public ContactKRISHNA PANDEY
ICMR-RMRIMS, Patna
Outcome results
None listed