Cutaneous leishmaniasis. Cutaneous leishmaniasis
Conditions
Interventions
Intervention 1: Intervention Group A: Receives miltefosine (2.5 mg/kg) plus a placebo.(wt > 45 kg = 50 mg x TDS, < 45 kg 50mg x BID, max dose 150 mg /day) for 28 days. Intervention 2: Intervention gro
Sponsors
CMH Quetta
Eligibility
Sex/Gender
All
Age
15 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients of both genders, aged 18-65 years with biopsy-proven cutaneous leishmaniasis.Plus • Positive LD bodies smear on Giemsa stain • Lesions in sites not responding to local treatment or meeting WHO guidelines • Multiple lesions on body • Lesions on lower legs, over a joint, mucosa or cartilage • Lesions located on sites not compatible with local treatment • Lesions that are potentially disfiguring or disabling (i.e. on face, fingers or toes)
Exclusion criteria
Exclusion criteria: • People with comorbidity(diabetes, hypertension, chronic liver diseases, chronic kidney disease) and or immunocompromised • Allergy to Allopurinol,miltefosine and previous history of drug reactions to any drug. • Has lesions that are limited in size (papules, nodules or ulcerated nodules) • The lesion is already self-curing • Patients enrolled in other research protocols • Pregnant and breast feeding women • Those who refused to accept the diagnostic procedures • Children under 12 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing of lesion in response to treatment. Timepoint: before intervention and 2, 4 , 6 and 8 weeks after intervention until complete healing occur than patient called for follow-up after one month. Method of measurement: Clinical Response Evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Any side effects during leishmaniasis treament. Timepoint: 2,4 ,6 ,8 weeks and 3 months after treatment. Method of measurement: interviewing with the patients and clinical examination. | — |
Countries
Pakistan
Contacts
Public ContactDr sammara sarwar
CMH Quetta
Outcome results
None listed