JMIR Publications

ABSTRACT

Background:

A dietary supplement with Pelargonium sidoides extract, propolis, zinc and honey has been recently developed and has proven to be an effective adjuvant in clinical practice for seasonal diseases and the treatment of respiratory tract disorders.

Objective:

The aim of the present trial is to verify the efficacy of the tested dietary supplement in a pediatric population with acute tonsillopharyngitis/rhinopharyngitis.

Methods:

The trial includes children aged 3-10 years with acute tonsillopharyngitis/rhinopharyngitis ≤ 48 h, negative rapid test for beta-hemolytic Streptococcus or culture and identification of nasal and/or pharyngeal exudates, and SARS-COV-2 infection. The study design is open-label, randomized, and controlled, with the tested dietary supplement plus standard of care (SoC) versus SoC alone. Patients are enrolled from three sites in Romania. The change in Tonsillitis Severity Score and number of treatment failures (using ibuprofen or high-dose paracetamol as rescue medication) are the primary endpoints. Based on the Tonsillitis Severity Score and the 2-sample comparison of the means formula with a 5% significance level, 80% power, and a minimally clinically important difference of 2 ±3.85 points, 120 patients are required. To account for potential screening failures and dropouts, we need to screen a population of approximately 150 children.

Results:

Patient recruitment started on June 3rd, 2021 (First Patient First Visit) and ended on August 12th, 2021 (Last Patient Last Visit). The analyses of the collected data are currently ongoing.

Conclusions:

The data from the present trial may be helpful in identifying new adjuvant treatment for children affected by acute tonsillopharyngitis/rhinopharyngitis when streptococcal infection is excluded by a negative rapid test, thereby avoiding unnecessary antibiotic administration. Clinical Trial: Clinical Trials.gov NCT04899401 https://clinicaltrials.gov/ct2/results?cond=&term=pediaflu&cntry=&state=&city=&dist=