Effect of Hiwa syrup, a Persian Medicine Product, on Autism Symptoms and in Children with Autism Spectrum Disorders: A Randomized Double-Blinded Clinical Trial

Background: Autism spectrum disorder (ASD) is a complex condition that affects communication, social interaction, and behavior. This study aims to evaluate the effectiveness of a Persian Medicine product, Hiwa syrup, which consists of consisted of apple (Malus domestica Borkh.) fruit, quince (Cydonia Oblonga Mill.) fruit, basil (Ocimum basilicum L.), green cardamom (Elettaria cardamomum), and sandalwood (Santalum album Linn), in ameliorating autism symptoms and extending eye contact duration in children diagnosed with ASD. Methods: A double-blind randomized clinical trial involved 60 children (3-5 years) with level 1 autism, randomly assigned to intervention and control (placebo) groups. The intervention group received Hiwa syrup for eight weeks alongside routine therapy. Autism status was assessed using Persian version of Gilliam Autism Rating 2nd edition (GARS-2) questionnaire, and eye contact duration in response to auditory stimuli was measured pre and post-intervention. SPSS software version 25.0 was used for data analysis. Results: The Hiwa syrup group exhibited a significant decrease in the mean GARS-2 score from 75.03 ± 7.83 to 69.47 ± 5.87 (p=0.01) with a mean difference of 5.56 ± 3.12. This decrease surpassed that of the placebo group. Furthermore, the intervention group showed a significant increase in eye contact duration, from (7.90 ± 3.81 seconds to 9.26 ± 3.21 seconds (p=0.05), with a mean difference of 1.36±1.88 seconds. In contrast, the placebo group exhibited a smaller increase, from (7.50 ± 2.21seconds to 7.83 ± 2.91 seconds (p=0.64), with a mean difference of 0.33 ± 0.48 seconds. Conclusion:The polyherbal product from Persian Medicine appears to be effective in ameliorating autism symptoms and extending the duration of eye contact in children diagnosed with autism spectrum disorders. Further clinical trials are essential to validate the efficacy of this product in treating autism spectrum disorders.