A polycentric, randomized, double blind, parallel-group, placebo-controlled study on Lertal®, a multicomponent nutraceutical, as add-on treatment in children with allergic rhinoconjunctivitis: phase I during active treatment

Italian Study Group on Pediatric Allergic Rhinoconjunctivitis

Research output: Contribution to journalLetter

1 Citation (Scopus)

Abstract

Allergic rhinoconjunctivitis (AR) treatment is usually pharmacological in children, but medications are merely symptomatic, may not be completely effective, and may have relevant side effects. Thus, doctors and parents look at complementary medicine, including nutraceuticals. Lertal®, an oral nutraceutical, contains extract of Perilla, quercetin, and Vitamin D3 It has been reported that adults with AR diminished allergic symptoms and medication use during Lertal® therapy. Therefore, the current polycentric, randomized, double blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of Lertal® as an add-on treatment in children with AR. In this study, 146 children (94 males and 52 females, mean age 9.1±1.88) were randomly assigned to Lertal® + standard treatment or Placebo + standard treatment and were visited at baseline (W0), and after 2 (W2) and 4 weeks (W4). Standard treatment consisted of continuous antihistaminic schedule. The primary endpoint was the Total Symptom Score (TSS - last 12 hours) change from the baseline to the end of the 4-week treatment. Both groups significantly (p less 0.0001 for both) reduced TSS (last 12 hours) after 4 weeks (% change: - 63.6% in Lertal®-group and - 60.7% in Placebo-group; p= n.s. intergroup analysis). Notably, 24 children had symptom worsening between W2 and W4: 8 in the Lertal®-group and 16 in the Placebo-group, with significant intergroup difference (p less than 0.05). All of them were poly-allergic subjects exposed to multiple allergens. There was no relevant adverse event. The present study documented that Lertal®, as add-on treatment, was able to significantly prevent the occurrence of clinical worsening and was safe in AR poly-allergic children.

Original languageEnglish
Pages (from-to)617-622
Number of pages6
JournalJournal of Biological Regulators and Homeostatic Agents
Volume33
Issue number2
Publication statusPublished - Mar 1 2019

Fingerprint

Dietary Supplements
Placebos
Therapeutics
Perilla
Cholecalciferol
Quercetin
Complementary Therapies
Allergens
Appointments and Schedules
Parents
Pharmacology
Safety

Keywords

  • add-on treatment
  • allergic rhinoconjunctivitis
  • nutraceutical
  • Perilla frutescens
  • quercetin
  • vitamin D3

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Immunology and Allergy
  • Physiology
  • Immunology
  • Oncology
  • Endocrinology
  • Physiology (medical)
  • Cancer Research

Cite this

@article{b4e312eac1614ff3906001a32bc46917,
title = "A polycentric, randomized, double blind, parallel-group, placebo-controlled study on Lertal{\circledR}, a multicomponent nutraceutical, as add-on treatment in children with allergic rhinoconjunctivitis: phase I during active treatment",
abstract = "Allergic rhinoconjunctivitis (AR) treatment is usually pharmacological in children, but medications are merely symptomatic, may not be completely effective, and may have relevant side effects. Thus, doctors and parents look at complementary medicine, including nutraceuticals. Lertal{\circledR}, an oral nutraceutical, contains extract of Perilla, quercetin, and Vitamin D3 It has been reported that adults with AR diminished allergic symptoms and medication use during Lertal{\circledR} therapy. Therefore, the current polycentric, randomized, double blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of Lertal{\circledR} as an add-on treatment in children with AR. In this study, 146 children (94 males and 52 females, mean age 9.1±1.88) were randomly assigned to Lertal{\circledR} + standard treatment or Placebo + standard treatment and were visited at baseline (W0), and after 2 (W2) and 4 weeks (W4). Standard treatment consisted of continuous antihistaminic schedule. The primary endpoint was the Total Symptom Score (TSS - last 12 hours) change from the baseline to the end of the 4-week treatment. Both groups significantly (p less 0.0001 for both) reduced TSS (last 12 hours) after 4 weeks ({\%} change: - 63.6{\%} in Lertal{\circledR}-group and - 60.7{\%} in Placebo-group; p= n.s. intergroup analysis). Notably, 24 children had symptom worsening between W2 and W4: 8 in the Lertal{\circledR}-group and 16 in the Placebo-group, with significant intergroup difference (p less than 0.05). All of them were poly-allergic subjects exposed to multiple allergens. There was no relevant adverse event. The present study documented that Lertal{\circledR}, as add-on treatment, was able to significantly prevent the occurrence of clinical worsening and was safe in AR poly-allergic children.",
keywords = "add-on treatment, allergic rhinoconjunctivitis, nutraceutical, Perilla frutescens, quercetin, vitamin D3",
author = "{Italian Study Group on Pediatric Allergic Rhinoconjunctivitis} and Marseglia, {G. L.} and A. Licari and G. Ciprandi",
year = "2019",
month = "3",
day = "1",
language = "English",
volume = "33",
pages = "617--622",
journal = "Journal of Biological Regulators and Homeostatic Agents",
issn = "0393-974X",
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T1 - A polycentric, randomized, double blind, parallel-group, placebo-controlled study on Lertal®, a multicomponent nutraceutical, as add-on treatment in children with allergic rhinoconjunctivitis

T2 - phase I during active treatment

AU - Italian Study Group on Pediatric Allergic Rhinoconjunctivitis

AU - Marseglia, G. L.

AU - Licari, A.

AU - Ciprandi, G.

PY - 2019/3/1

Y1 - 2019/3/1

N2 - Allergic rhinoconjunctivitis (AR) treatment is usually pharmacological in children, but medications are merely symptomatic, may not be completely effective, and may have relevant side effects. Thus, doctors and parents look at complementary medicine, including nutraceuticals. Lertal®, an oral nutraceutical, contains extract of Perilla, quercetin, and Vitamin D3 It has been reported that adults with AR diminished allergic symptoms and medication use during Lertal® therapy. Therefore, the current polycentric, randomized, double blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of Lertal® as an add-on treatment in children with AR. In this study, 146 children (94 males and 52 females, mean age 9.1±1.88) were randomly assigned to Lertal® + standard treatment or Placebo + standard treatment and were visited at baseline (W0), and after 2 (W2) and 4 weeks (W4). Standard treatment consisted of continuous antihistaminic schedule. The primary endpoint was the Total Symptom Score (TSS - last 12 hours) change from the baseline to the end of the 4-week treatment. Both groups significantly (p less 0.0001 for both) reduced TSS (last 12 hours) after 4 weeks (% change: - 63.6% in Lertal®-group and - 60.7% in Placebo-group; p= n.s. intergroup analysis). Notably, 24 children had symptom worsening between W2 and W4: 8 in the Lertal®-group and 16 in the Placebo-group, with significant intergroup difference (p less than 0.05). All of them were poly-allergic subjects exposed to multiple allergens. There was no relevant adverse event. The present study documented that Lertal®, as add-on treatment, was able to significantly prevent the occurrence of clinical worsening and was safe in AR poly-allergic children.

AB - Allergic rhinoconjunctivitis (AR) treatment is usually pharmacological in children, but medications are merely symptomatic, may not be completely effective, and may have relevant side effects. Thus, doctors and parents look at complementary medicine, including nutraceuticals. Lertal®, an oral nutraceutical, contains extract of Perilla, quercetin, and Vitamin D3 It has been reported that adults with AR diminished allergic symptoms and medication use during Lertal® therapy. Therefore, the current polycentric, randomized, double blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of Lertal® as an add-on treatment in children with AR. In this study, 146 children (94 males and 52 females, mean age 9.1±1.88) were randomly assigned to Lertal® + standard treatment or Placebo + standard treatment and were visited at baseline (W0), and after 2 (W2) and 4 weeks (W4). Standard treatment consisted of continuous antihistaminic schedule. The primary endpoint was the Total Symptom Score (TSS - last 12 hours) change from the baseline to the end of the 4-week treatment. Both groups significantly (p less 0.0001 for both) reduced TSS (last 12 hours) after 4 weeks (% change: - 63.6% in Lertal®-group and - 60.7% in Placebo-group; p= n.s. intergroup analysis). Notably, 24 children had symptom worsening between W2 and W4: 8 in the Lertal®-group and 16 in the Placebo-group, with significant intergroup difference (p less than 0.05). All of them were poly-allergic subjects exposed to multiple allergens. There was no relevant adverse event. The present study documented that Lertal®, as add-on treatment, was able to significantly prevent the occurrence of clinical worsening and was safe in AR poly-allergic children.

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KW - Perilla frutescens

KW - quercetin

KW - vitamin D3

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VL - 33

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