Health Condition 1: null- Suffering from Post Kala Azar Dermal Leishmaniasis
Conditions
Interventions
None listed
Sponsors
Department of Pharmacology
Eligibility
Inclusion criteria
Inclusion criteria: 1)A clinical diagnosis of active PKDL with characteristic skin lesion. 2)Confirmed diagnosis with biopsy of the skin (lesional segment) lesion. 3)Male or female of age 18-65 yrs.
Exclusion criteria
Exclusion criteria: 1)Pregnant or lactating women 2)Refusal to use contraceptives during the treatment period and 2 months after completion of treatment with miltefosine 3) HIV positive serology. 4)Patients with co-morbid liver, kidney diseases 5)Anaphylactic reaction with Amphotericin B
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)To assess the effectiveness of Liposomal Amphotericin B (LAmB) versus Miltefosine in patients of Post Kala-azar Dermal Leishmaniasis (PKDL) 2)To compare the safety of the two treatments. Timepoint: 0 weeks , 4 weeks and 24 weeks from the date commencement of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)To estimate the compliance to therapy of the two groups. 2)To compare the quality of life in both the treatment arms. Timepoint: 0 weeks , 4 weeks and 24 weeks from the date commencement of the study | — |
Countries
India
Contacts
Public ContactDr Mitali Chatterjee
Department of Pharmacology INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH
Outcome results
None listed