Related Experiment Video
Updated: Jan 22, 2026

Behavioral Disturbances: An Innovative Approach to Monitor the Modulatory Effects of a Nutraceutical Diet
Published on: January 3, 2017
A polycentric, randomized, parallel-group, study on Lertal®, a multicomponent nutraceutical, as preventive treatment
Gianluigi Marseglia1, Amelia Licari1, Salvatore Leonardi2
1Pediatrics Clinic, Pediatrics Department, Policlinico San Matteo, University of Pavia, Pavia, Italy.
Insights
This study found that Lertal®, a nutraceutical, significantly reduced allergic rhinitis (AR) exacerbations in children. Continued Lertal® use halved the risk and duration of AR symptoms, ensuring longer symptom-free periods.
Area of Science:
- Allergy and Immunology
- Pediatrics
- Nutraceutical Research
Background:
- Allergic rhinitis (AR) poses a significant health challenge in children.
- Nutraceuticals offer a potential avenue for managing chronic conditions like AR.
- Lertal®, containing Perilla extract, quercetin, and Vitamin D3, was investigated for its efficacy in AR management.
Purpose of the Study:
- To evaluate the efficacy and safety of Lertal® in preventing allergic rhinitis exacerbations in children.
- To assess the impact of Lertal® on the frequency, intensity, and duration of AR exacerbations.
- To determine the effect of Lertal® on symptom-free time in pediatric AR patients post-pharmacological treatment.
Main Methods:
- A polycentric, randomized, parallel-group, controlled Phase II study was conducted.
- 128 children with AR were divided into two groups: continued Lertal® (LG) or no medication (OG) for 4-12 weeks.
- Study endpoints included AR exacerbation rates, intensity, duration, and symptom-free intervals.
Main Results:
- Lertal® group (LG) showed a 54% reduced risk of AR exacerbations compared to the observation group (OG).
- LG patients experienced significantly fewer AR exacerbations and required less rescue medication.
- Prolonged Lertal® use was associated with significantly longer symptom-free periods and no adverse events.
Conclusions:
- Lertal® is a safe and effective nutraceutical for preventing allergic rhinitis exacerbations in children.
- Sustained Lertal® intake significantly reduces AR symptom severity, duration, and the need for rescue medications.
- Lertal® demonstrates potential as a long-term preventive strategy for pediatric allergic rhinitis, promoting extended symptom relief.
Background:
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.
Materials And Methods:
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.
Results:
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.
Conclusions:
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.
Trial Registration:
Clinical trial registration: ClinicalTrials gov ID NCT03365648 .
Related Concept Videos
Allergic Reactions
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
Allergic Drug Reactions
Parallel Resonance
Parallel Processing
Acute Kidney Injury IV: Diagnostic Studies and Prevention

