Kochar 2000

Methods	Study design: randomised controlled trial Setting/location: India Study period: 5 months Sample size calculation: not described
Participants	Type of Leishmania: L tropica Inclusion criteria: participants with a confirmed diagnosis of L tropica. The diagnosis was confirmed by demonstrations of L tropica bodies (amastigote stage of L tropica under oil immersion). Exclusion criteria: no mention about inclusion or exclusion criteria N randomised: 50. Rifampicin 1200 mg/d orally: 25; placebo: 25 Withdrawals: 4. Rifampicin 1: 2 (lost to follow‐up); placebo: 2 (withdrew due to exacerbation of lesions) N assessed: 46. Rifampicin: 23; placebo: 23 Mean (SD) age: rifampicin 29.54 years (17.34); placebo: 26.96 years (10.96) Sex (male/female): rifampicin: 10/13; placebo: 9/14 Baseline data: Type of lesions (% rifampicin versus placebo): ulcerative: 21.7 versus 17.4, nodular: 30.4 versus 30.4; nodule‐ulcerative: 17.4 versus 30.4, and erythematous plaques: 30.4 versus 21.7. Regarding the distribution (%): face: 17.5 versus 20.9; neck; 3.5 versus 0; shoulder: 1.75 versus 0; arms: 17.5 versus 20.9; hand: 19.2 versus 18.6; legs: 28 versus 16.2; feet: 8.77 versus 20.9, and abdomen: 3.5 versus 2.32 Mean number of lesions (SD): rifampicin 2.92 (4.61); placebo 2.08 (0.78) Mean duration of lesions (SD): rifampicin 3.58 months (6.14); placebo: 3.23 months (2.93) Mean size of lesions (SD): rifampicin 31.91 mm² (15.99); placebo: 37.04 mm² (12.37)
Interventions	Type of interventions: Group 1: rifampicin 1200 mg/d orally Group 2: placebo capsules orally Duration of intervention: 2 divided doses for 4 weeks Duration of follow‐up: 4 weeks Co‐interventions: the 2 withdrew due to exacerbation of lesions in placebo group and were treated by another therapeutic regimen
Outcomes	Healing rates: percentage of participants 'cured' at the end of treatment: a cure was defined as complete healing and disappearance of the lesion or reversible hypopigmentation at the site of lesion. Incomplete or partial healing was defined as a reduction in the size of a lesion and the absence of parasites on smear. A treatment failure or non‐healing was defined as the absence of any change in the lesion and persistence of parasites on smear Adverse effects Tertiary outcomes: microbiological or histopathological cure of skin lesions Time points reported: at the end of the treatment
Notes	Study funding sources: not reported Possible conflicts of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Randomized" Comment: insufficient detail was reported about the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	Comment: "Randomized" but no further information provided
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: "Double‐blinded" but no further information provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: "Double‐blinded" but no further information provided
Incomplete outcome data (attrition bias) All outcomes	Low risk	Missing outcome data balanced in numbers across intervention groups
Selective reporting (reporting bias)	Low risk	Comment: all relevant outcomes were reported
Other bias	Unclear risk	There was not enough information in the publication to assess if there were other biases present.