Trial | NCT03365648  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
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.
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.
Study Started
Sep 15
2017
Primary Completion
Jul 04
2018
Study Completion
Nov 13
2018
Last Update
Nov 15
2018

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

Lertal® + standard therapy Experimental

Lertal® double-layer tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine)

Placebo + standard therapy Placebo Comparator

Placebo tablets (1 tab/day for 4 weeks) plus standard therapy (antihistamine)

Criteria 

Inclusion Criteria:

Age 6 to 12 years
Male or female
Diagnosis of allergic rhinoconjunctivitis
Hypersensitivity to dust mites or pollen confirmed with skin-prick test (wheal and redness, ≥ 3 mm more extended than control) performed in the previous 12 months
Total Symptoms Score (TSS) ≥ 15 and at least 1 for nasal congestion
Written informed consent of patient and of parent or legal guardian

Exclusion Criteria:

Uncontrolled asthma
Secondary rhinitis to other causes
Documented evidence of acute or chronic sinusitis
Nasal polyps
Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or topical corticosteroids
Use of leukotriene antagonists
Continuous use of antihistamines

Inadequate washout of drugs:

Systemic or intranasal corticosteroids: 1 month
Leukotriene antagonists: 1 month
Sodium cromoglycate: 2 weeks
Systemic or intranasal decongestants: 3 days
Cetirizine, fexofenadine, loratadine, desloratadine, hydroxyzine: 5-10 days
Malformations of the nose, ear or throat
Upper or lower respiratory tract infection in the last 2 weeks
Participation in other clinical studies in the last month
Documented hypersensitivity to the study product or its excipients
Trip planned outside of the study area
No Results Posted