| Methods |
Study design: randomised controlled trial Setting/location: skin department of PNS Shifa, a naval hospital in Karachi. Endemic areas of Balochistan province, Pakistan Study period: not described Sample size calculation: not described |
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| Participants |
Type of Leishmania: Leishmania spp not mentioned Inclusion criteria: never received any treatment for their skin disease Exclusion criteria: very young and very old people, those who had received some treatment for the disease, people suffering from diffuse CL or leishmaniasis recidivans, people with some known cardiac, renal or hepatic disease N randomised: 40. 20 in each group Withdrawals: 0 Participants assessed: 40 (100%). 20 in each group Age: range 20‐40 Sex: 100% male Baseline data. Nodular, ulcerative and crusted forms were the most common morphological patterns seen. Most lesions were on hands and feet.
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| Interventions |
Type of interventions:
Duration of intervention: 15 days Duration of follow‐up: 3 months |
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| Outcomes |
Healing rates: percentage of participants 'cured' at the end of treatment Adverse effects Time points reported: at the end of treatment |
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| Notes |
Study funding sources: not reported Possible conflicts of interest: none declared |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: insufficient detail was reported about the method used to generate the allocation sequence. |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not described |
| Selective reporting (reporting bias) | Low risk | The study protocol is not available but it is probably that the published reports include all expected outcomes |
| Other bias | High risk | Sample size calculation and reporting of Leishmania spp involved was not correctly reported |