An observational study for Safety and efficacy of a combination of Paromomycin and Miltefosine in patients with Post Kala-Azar Dermal Leishmaniasis (PKDL).
- Conditions
- Health Condition 1: null- Post Kala-azar Dermal Leishmaniasis (PKDL)
- Registration Number
- CTRI/2016/04/006898
- Lead Sponsor
- Intramural project of RMRIMS ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
• Male or female patients aged 5-65years
• Post kala azar dermal leishmaniasis (PKDL), parasitologically confirmed (amastigotes in slit-skin or snip skin smears and/or skin biopsies)
• Macules, nodules and papules or plaques as clinical signs consistent with post Kala-azar dermal Leishmaniasis
• Any patients having any ear deformity, hearing loss and ASOM/CSOM.
• Pregnant and lactating females.
• Females not willing for contraception.
• Patients not willing to participate.
• Thrombocyte count <100 x 109/l
• Leukocyte count <2.5 x 109/l
• Hemoglobin < 8.0 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
• Hypersensitivity to miltefosine, paromomycin or inactive ingredients of miltefosine
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method