Methods |
Study design: randomised controlled trial Setting/location: Iran Study period: 24 months Sample size calculation: yes |
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Participants |
Type of Leishmania:L major Inclusion criteria: CL confirmed with direct smear, age 5‐50 years, maximum number of lesions 3, duration of disease < 100 days Exclusion criteria: previous treatment for leishmaniasis, use of immunosuppressives, history of chronic systemic disease, lesions on face, pregnancy or lactating, age < 5 years, duration of disease > 100 days N randomised: 197 Withdrawals: 26 N assessed: 171. 96 were treated with garlic 5% cream and 75 with vehicle Mean age: garlic, 18.5 years; vehicle, 23.7 years Sex (male/female): garlic, 51/45; placebo, 38/37 Baseline data: not reported |
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Interventions |
Type of interventions:
Duration of intervention: both applied twice daily under occlusion with sterile gauze for 3 hours, for 20 days Duration of follow‐up: 60 days (after the 3 week treatment, participants were followed for another period of 40 days) |
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Outcomes |
Healing rates: percentage of participants 'cured' one month (40 days) after treatment Time points reported: yes |
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Notes |
Study funding sources: none reported Possible conflicts of interest: none declared We only have the abstract. The author (A Khamesipour) was contacted and kindly agreed to extract the data from the original paper written in Persian. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | List generated by a computer |
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 | Low risk | Low rates of dropouts (26/197; < 25%) |
Selective reporting (reporting bias) | Unclear risk | All relevant outcomes reported |
Other bias | Unclear risk | There was not enough information in the publication to assess if there were other biases present. |