Zerehsaz 1999

Methods	Study design: randomised controlled trial Setting/location: Fars province, Iran Study period: not described Sample size calculation: not described
Participants	Type of Leishmania: Leishmania spp: L major and L tropica in the area Inclusion criteria: diagnosed as having CL based on positive smears from lesions, and in some cases, cultures and histopathologic studies were also performed. Exclusion criteria: pregnant, nursing, or serious concomitant diseases. N randomised: 171 Withdrawals: 0 N assessed: 171 participants: 86 participants in the herbal extract Z‐HE group and 85 participants in the IMMA (15 to 20 mg/kg/d) Age: range 10 months to 69 years Sex (male/female): 84/87 Baseline data: the duration of the disease was < 4 months. Most participants had papular and papulonodular lesion(s), although other clinical forms including ulcerative, eczematoid, hyperkeratotic, and erysipeloid types were also present. Most participants had multiple lesions, and the most common sites were the face and the extremities.
Interventions	Type of interventions: Group 1: herbal extract Z‐HE as a black paste applied to the lesions and covered by a dressing for 5 consecutive days + placebo (saline) injected (0.5 mL) for 20 consecutive days Group 2: IMMA (15‐20 mg/kg/d) for 20 consecutive days + vehicle (petrolatum and charcoal powder) applied on the lesions as a black paste covered by a dressing for 5 consecutive days Duration of intervention: 20 consecutive days
Outcomes	Healing rates: complete cure was defined as clinical improvement with complete healing and re‐epithelialisation of the lesion(s), partial cure as partial clinical improvement with reduction in infiltration erythema, and size of the lesion(s), and failure as the absence of any changes in the lesion(s) or progression and worsening of the lesion(s) Adverse effects Time points reported: 6 weeks post‐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	Comment: insufficient detail was reported about the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	Insufficient information about the sequence generation process to permit judgment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgment
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing outcome data.
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgment
Other bias	High risk	Sample size calculation and reporting of Leishmania spp involved was not correctly reported