Efficacy and safety of Pranabb® syrup to reduce cough and improve sleep quality in children compared to usual recommended hydration measures

Abstract

Background: Coughing is crucial for protecting the airways, but associated to unpleasant symptoms that often lead to pediatrician visits. Natural remedies like honey and essentials oils are being increasingly used to effectively relieve symptoms associated with cough. Objectives: Evaluate the efficacy and safety of Pranabb® cough syrup, an organic honey-based natural formulation tailored for pediatric patients, in relieving cough symptoms. Methods: One-week multicenter comparative clinical study of 50 children, 28 in the treatment group and 22 in the control group with supportive measures (increased hydration). Pediatrician appointments were scheduled at the baseline and on day 7, with a progress check call on day 3. Parents kept a daily cough diary. Results: Day 3 results show a significant decrease in daytime cough, night-time cough and global score more pronounced and statistically significant in the study group, although the more severe baseline level in the study group. On day 7, decrease in daytime and overall cough scores was greater in the study group (p<0.05). The frequency of awakenings due to coughing decreased on day 3 only in the study group (p<0.05) and on day 7 for both groups, although it was higher and more significant in the study group (-1.82 p<0.01 vs -1.25 p<0.05). In addition, the safety analysis confirms that the syrup is not toxic to children. Conclusion: Pranabb® Cough Syrup is safe and effective, reducing cough severity and nighttime awakenings in children and improving parents’ ability to sleep. More randomized clinical trials will be interesting to get more homogeneity between the two groups at baseline.