Skip to main content
. 2017 Nov 17;2017(11):CD005067. doi: 10.1002/14651858.CD005067.pub4
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
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
Interventions Type of interventions:
  • Group 1: Cassia fistula fruit gel + ILMA

  • Group 2: vehicle gel + ILMA


Duration of intervention: not described
Outcomes Cure: complete cure, partial cure and treatment failure
Adverse effects (itching and erythema)
Time points reported: 12 weeks
Notes Study funding sources: not reported
Possible conflicts of interest: none declared
We only have the abstract
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