A polycentric, randomized, parallel-group, study on Lertal?, a multicomponent nutraceutical, as preventive treatment in children with allergic rhinoconjunctivitis: phase II

摘要

Lertal?, an oral nutraceutical, contains extract of Perilla, quercetin, and Vitamin D3. The current polycentric, randomized, parallel-group, controlled study aimed in the Phase II to evaluate the efficacy and safety of Lertal? in preventing allergic rhinitis (AR) exacerbations in children after the end of the pharmacological treatment phase. One hundred twenty-eight children completed Phase II. Sixty-four children continued Lertal? treatment (Lertal? Group: LG) and 64 ones did not assume any medication (Observation Group: OG) for 4–12?weeks. The study endpoints were the number, intensity, and duration of AR exacerbations, and the length of symptom-free time. Children of LG halved the risk (HR?=?0.54) of having AR exacerbation. Children of LG had significantly (p?=?0.039) less AR exacerbations than OG children. In children with AR exacerbations, the total number of days in which each patient took at least one rescue medication was significantly (p?=?0.018) lesser in LG children than OG ones. In the global population, the cumulative days treated with rescue medication was significantly (p??0.0001) higher in OG than in LG. There was no clinically relevant adverse event. The present study documented that prolonged Lertal? assumption was safe and able to significantly reduce, such as halving, the risk of AR exacerbation, their duration and the use of rescue medications, after the suspension of the one-month antihistamine treatment. Therefore, Lertal? could be envisaged as an effective preventive treatment in AR children able to guarantee long symptom-free time. Clinical trial registration: ClinicalTrials gov ID NCT03365648 .