Aim: The purpose of this study was to evaluate the effectiveness and safety of Aromaforce®
Junior Cough Syrup (AJCS) in treating acute upper respiratory tract infection-related
coughs in children, and it served as a post-marketing clinical follow-up.
Methods: Prospective, multicenter, open-label, controlled clinical investigation conducted
under normal conditions of use to evaluate the antitussive effectiveness of a mucilage-based syrup in pediatric patients (aged 2 to 12 years) as compared to increased hydration
measures (control group), with a 1-week follow-up. Likert severity scores were used to
evaluate coughs and related symptom severity.
Results: The results demonstrate that AJCS effectively reduces cough severity, including
daytime and night-time cough, and the number of times the child was woken up, particularly
within the first three days, surpassing the effectiveness of hydration measures. The results
of the degree of satisfaction with AJCS show that the majority of physicians and parents had
positive feedback. Furthermore, the safety analysis confirms the syrup’s non-toxic nature
in children. However, the initial differences in baseline characteristics between the study
and control groups, with the study group exhibiting higher combined cough scores, limit
the strength of the evidence.
Conclusions: This study provides further evidence supporting the efficacy and safety of
AJCS in the treatment of cough associated with acute upper respiratory tract infections
in children. Further randomized studies may provide further evidence of the efficacy and
safety of AJCS.
syrup, cough, upper respiratory tract infection, protective barrier, essential oils