Open, Randomised, Controlled Study to Evaluate a Dietary Supplement with <i>Pelargonium sidoides</i> Extract, Honey, Propolis, and Zinc in Children with Acute Tonsillopharyngitis

Background/Objectives: Acute tonsillopharyngitis (ATR), typically caused by viruses, is a common reason for consultation with pediatricians. A dietary supplement with Pelargonium sidoides extract, propolis, honey, and zinc has been proposed as an effective adjuvant for the treatment of respiratory tract infections. This study aimed to verify, in a setting of standard clinical practice, the efficacy of this dietary supplement plus standard of care (SoC) versus SoC alone in a pediatric population affected by ATR. Methods: This open randomized study (registered on ClinicalTrials.gov: NCT 04899401) involved three Romanian sites specialized in pediatric care. The primary endpoints were changes in Tonsillitis Severity Score and the number of treatment failures (evaluating the use of ibuprofen or high-dose paracetamol as rescue medicine). One hundred and thirty children, divided into two groups, were enrolled and treated for six days. Results: The results showed an overall better performance in terms of efficacy of dietary supplement + SoC, compared to SoC alone, with lower total Tonsillitis Severity Score ratings and lower sub-scores (swallowing on day 4 and throat pain and erythema on day 6). No adverse events were reported. Investigators found compliance to be optimal. Conclusions: The administration of the dietary supplement + SoC in pediatric patients with ATR was found to be safe and superior to the administration of SoC alone in terms of efficacy. The results confirmed the tested dietary supplement as an optimal effective adjuvant in the treatment of respiratory tract infections and useful in the daily clinical practice of the paediatricians.