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An observational study for Safety and efficacy of a combination of Paromomycin and Miltefosine in patients with Post Kala-Azar Dermal Leishmaniasis (PKDL).

Safety and efficacy of a combination of Paromomycin and Miltefosine for two versus three courses in patients with Post Kala-Azar Dermal Leishmaniasis (PKDL) - an exploratory pilot Study - MP

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2016/04/006898
Enrollment
30
Registered
2016-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Post Kala-azar Dermal Leishmaniasis (PKDL)

Interventions

Intervention1: Combination of Miltefosine and Paromomycin: Nil

Sponsors

Intramural project of RMRIMS ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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 • Leukocyte count • Hemoglobin • 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

Design outcomes

Primary

MeasureTime frame
Three courses of combination of Paromomycin and Miltefosine in 30 patients of PKDL resulted in initial cure in 100% of patients. However five patients had relapse of lesions within 1 year follow-up.Timepoint: June 2013 to January 2016 including one year follow-up. Three courses of combination of Paromomycin and Miltefosine in 30 patients of PKDL resulted in initial cure in 100% of patients. However five patients had relapse of lesions within 1 year follow-up.—

Secondary

MeasureTime frame
Five patients out of thirty treated with Paromomycin and Miltefosine had relapse of the skin lesions within one year. However there was very slide change in the biochemical and haematological parameters.Timepoint: June 2013 to January 2016 including one year follow-up post treatment. Three courses of combination of Paromomycin and Miltefosine in 30 patients of PKDL resulted in initial cure in 100% of patients. However five patients had relapse of lesions within 1 year follow-up.—

Countries

India

Contacts

Public ContactDr Krishna Pandey

RAJENDRA MEMORIAL RESEARCH INSTITUTE OF MEDICAL SCIENCES (RMRIMS)

drkrishnapandey@yahoo.com9431042119

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026