A randomized double-blind study evaluating the safety and effectiveness of a Ghanaian polyherbal product for the management of superficial mycoses

A prospective randomised double blind parallel controlled trial was conducted to evaluate the safety and clinical effectiveness of a standardised Ghanaian polyherbal product EAF-2011 comprising: Alchornea cordifolia, Eugenia caryophyllata, Psidium guajava, Tridax procumbens and Zanthoxylum zanthoxyloides, used in the management of skin diseases.A total number of 84 participants aged between 8 and 45 years who were clinically diagnosed with superficial mycoses were recruited into the study and followed up for 4 months. Participants were randomised to receive 2%, 5% or 10% (w/w) concentrations of the finished herbal product or the control treatment of Whitfield ointment. Primary efficacy outcome (complete cure): defined as total signs and symptoms score (TSSS) of zero and where applicable mycological cure also defined as a negative mycological culture and microscopic examination was achieved by 30.0%, 34.78%, 75.0% and 91.30% of the control, 2%, 5% and 10% (w/w) EAF-2011 treatments respectively. Safety analyses using urine, biochemical and haematological parameters were normal at the end of the study. Also, no adverse reactions were recorded during the study. The study thus showed all the treatments to be safe and effective for the management of dermatophytes with 10% (w/w) finished herbal product being the most effective treatment.