Comparative study between Liposomal Amphoterisin B and Miltefosine in post kala azar dermal Leishmaniasis
Phase 4
- Conditions
- Health Condition 1: null- Suffering from Post Kala Azar Dermal Leishmaniasis
- Registration Number
- CTRI/2018/06/014579
- Lead Sponsor
- Department of Pharmacology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)To assess the effectiveness of Liposomal Amphotericin B (LAmB) versus Miltefosine in patients of Post Kala-azar Dermal Leishmaniasis (PKDL) <br/ ><br>2)To compare the safety of the two treatments. <br/ ><br>Timepoint: 0 weeks , 4 weeks and 24 weeks from the date commencement of the study
- Secondary Outcome Measures
Name Time Method 1)To estimate the compliance to therapy of the two groups. <br/ ><br>2)To compare the quality of life in both the treatment arms. <br/ ><br>Timepoint: 0 weeks , 4 weeks and 24 weeks from the date commencement of the study