Abstract
BackgroundLertal®, 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.Materials and methodsOne 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.ResultsChildren 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.ConclusionsThe 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.Trial registrationClinical trial registration: ClinicalTrials gov ID NCT03365648.
Highlights
Lertal®, an oral nutraceutical, contains extract of Perilla, quercetin, and Vitamin D3
The present study documented that prolonged Lertal® assumption was safe and able to significantly reduce, such as halving, the risk of allergic rhinitis (AR) exacerbation, their duration and the use of rescue medications, after the suspension of the one-month antihistamine treatment
Lertal® could be envisaged as an effective preventive treatment in AR children able to guarantee long symptom-free time
Summary
Lertal®, an oral nutraceutical, contains extract of Perilla, quercetin, and Vitamin D3. Antiallergic drugs, antihistamines (oral or nasal) and nasal corticosteroids, represent the standard therapy for AR These drugs may exert symptomatic relief of symptoms without persistent improvements of allergic disorder [3, 4]. Their discontinuation is associated with quick symptom and cellular infiltrate relapse. There is increasing interest for new treatments for children with AR [7] In this regard, there is evidence that nutraceuticals may be combined with standard therapy to speed up recovery, make it long lasting, avoid aggressive therapeutic regimens, and potentially prevent clinical relapse [8, 9]
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