Methods |
Study design: randomised controlled trial Setting/location: Skin Disease and Leishmaniasis Research Center of Isfahan (SDLRC), Iran Study period: not described Sample size calculation: not described |
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Participants |
Type of Leishmania: not described Inclusion criteria: not described Exclusion criteria: not described N randomised: 140 participants Withdrawals: 64 N assessed: 76 participants (47 with ILMA and topical Cassia fistula fruit gel and 29 participants in vehicle group) Age: not described Sex: not described Baseline data: not described |
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Interventions |
Type of interventions:
Duration of intervention: not described |
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Outcomes |
Cure: complete cure, partial cure and treatment failure Adverse effects (itching and erythema) Time points reported: 12 weeks |
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Notes |
Study funding sources: not reported Possible conflicts of interest: none declared We only have the abstract |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "140 patients with cutaneous leishmaniasis referring to Skin Diseases and Leishmaniasis Research Center of Isfahan (SDLRC) were randomly allocated in two groups" Comment: insufficient detail was reported about the method used to generate the allocation sequence. |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: the vehicle came exactly in the same colour and shape as the drug and the application procedure was also the same. We think the outcome is unlikely to be influenced by lack of blinding of personnel. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | There is no information about withdrawals. |
Selective reporting (reporting bias) | Low risk | Our primary outcomes (cured and adverse effects) were described in the Methods and reported in the text. |
Other bias | High risk | Sample size calculation, inclusion criteria, reporting of Leishmania spp involved and baseline comparability was not correctly reported |