CTRI/2018/06/014579
Recruiting
Phase 4
An Observational, prospective, comparative study of the effectiveness and safety of Liposomal Amphotericin-B versus Miltefosine in the treatment of Post Kala-Azar Dermal Leishmaniasis (PKDL).
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Suffering from Post Kala Azar Dermal Leishmaniasis
- Sponsor
- Department of Pharmacology
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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