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Comparison between two groups in the treatment of cutaneous leishmaniasis

Phase 3
Conditions
Cutaneous leishmaniasis.
Cutaneous leishmaniasis (any type)
Registration Number
IRCT138904091159N7
Lead Sponsor
Vice chancellor for research, Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
104
Inclusion Criteria

Inclusion Criteria: 1- Patients with a diagnosis of acute zoonotic cutaneous leishmaniasis has been proven parasitology by direct smear 2- Patients must be 18-50 age 3- Lesion diameter is not greater than 3 cm 4- The number of lesion is one 5- Lesions are not on the face near the eyes, joints, cartilage, on the nose and ears 6- Less than three months passed from diseases times.

Exclusion Criteria

1- The status of women in pregnancy and lactation 2- The risk of presence or incidence of sporotrichoid or Satellite lesions 3- Patients with a history of hepatitis, heart and kidney disorder 4- People who are taking immunosuppressive medications (over the last 6 months) 5- history of local or systemic treatment against leishmaniasis in the last 3 months 6- Patients with a history of heart attack or high blood pressure 7- Liver disease 8- Patients with anemia 9- Patients with a history of surgery for head and brain hemorrhage 10- Patients with blood pressure medications, antidepressants, or drugs used for angina.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
esion area. Timepoint: 8, 12, 20 weeks after end of treatment. Method of measurement: Pictzar software.;Induration. Timepoint: 1, 2, 3, 4, 7, 8, 12, 16, 20 weeks after end of treatment. Method of measurement: Physical examination.;Improvement rate. Timepoint: 1, 2, 3, 4, 7, 8 weeks during treatment and 12, 16, 20 weeks after end of treatment. Method of measurement: Observation and examination.
Secondary Outcome Measures
NameTimeMethod
Side effects. Timepoint: 3 months after treatment. Method of measurement: Observation and examination.
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