NCT03365648

Efficacy and Safety of Lertal® as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics

A Randomized, Double-blinded, Parallel-group, Placebo-controlled Clinical Study of the Efficacy and Safety of an Oral Nutraceutical (Lertal®) as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: NTC srl · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Lertal® as an add-on treatment for children affected by allergic rhinoconjunctivitis.

Detailed description

Allergic rhinoconjunctivitis (AR) is a common chronic disorder in children, especially in developed countries. It is not characterized by nasal symptoms only (such as congestion and sneezing), but may also cause general complaints such as fatigue and cough. AR can also have detrimental effects on mood, sleep, social activities and scholastic performance. Lertal® is a novel nutraceutical containing seed extracts from Perilla Frutescens, Quercetin extracted from Sophora japonica and Vitamin D3, all compounds that have demonstrated their ability to reduce allergy symptoms and the use of anti-allergy drugs in adults. The aim of this randomized, double-blinded, parallel-group, placebo-controlled study is to evaluate the efficacy and safety of Lertal® as an add-on treatment for children affected by allergic rhinoconjunctivitis.

Conditions

• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lertal® + standard therapy	Lertal® is a novel food supplement. Each tablet contains the following active ingredients: * Quercetin 150 mg: a natural flavonoid that inhibits the release of histamine, leukotrienes, PGD2, IL (IL-6, IL-8, TNF-alpha). * Perilla frutescens 80 mg: A dry extract of the seeds containing rosmarinic acid, luteolin, apigenin and crysoeriol that inhibits the release of histamine and expression of interleukins (IL-6, TNF-alpha). * Vitamin D3 5 mcg (200 IU), which contributes to the normal function of the immune system. Standard therapy: antihistamine.
OTHER	Placebo + standard therapy	Placebo tablet identical in appearance, size and taste to Lertal® tablets. Standard therapy: antihistamine. Standard therapy: antihistamine

Timeline

• Start date: 2017-09-15
• Primary completion: 2018-07-04
• Completion: 2018-11-13
• First posted: 2017-12-07
• Last updated: 2018-11-15

Locations

17 sites across 1 country: Italy