A observational study for effects of Amphotericin B in two different doses in Post Kala-Azar Dermal Leishmaniasis (PKDL)
Not Applicable
Completed
- Conditions
- Health Condition 1: null- PKDL (Post Kala-azar Dermal Leishmaniasis) Patients
- Registration Number
- CTRI/2016/05/006958
- Lead Sponsor
- Intramural Projects of RMRIMS ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
• Both sex patients aged 5-60 years
• Parasitologically confirmed Post kala azar
dermal leishmaniasis (PKDL)
• All types of PKDL
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 <100 x 109/l
• Leukocyte count <2.5 x 109/l
• Hemoglobin < 6.0 g/100 ml
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary out come: Initial cure rate was 92% and 88% in group A and Group B respectively. <br/ ><br>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 Outcome Measures
Name Time Method Final cure rate 88 % and 84 %Timepoint: one year