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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
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.
Age
6 - 12 years
Sex
ALL
Healthy Volunteers
No
Fondazione IRCCS Policlinico San Matteo
Pavia, (PV), Italy
Ospedale regionale San Salvatore - ASL 1 Avezzano Sulmona L'Aquila
L’Aquila, AQ, Italy
A.O.U. Consorziale "Policlinico Giovanni XXIII"
Bari, BA, Italy
A.O.U. Consorziale "Policlinico-Giovanni XXIII"
Bari, BA, Italy
A.O.U. Policlinico Vittorio Emanuele
Catania, CT, Italy
Istituto Giannina Gaslini
Genova, GE, Italy
P.O. San Giovanni di Dio - ASP di Crotone
Crotone, KR, Italy
A.O.U. Policlinico "G. Martino"
Messina, ME, Italy
P.O. G. Salvini di Garbagnate Milanese - ASST Rhodense
Garbagnate Milanese, MI, Italy
Ospedale Civile di Legnano - ASST Ovest Milanese
Legnano, MI, Italy
Start Date
September 15, 2017
Primary Completion Date
July 4, 2018
Completion Date
November 13, 2018
Last Updated
November 15, 2018
150
ACTUAL participants
Lertal® + standard therapy
DIETARY_SUPPLEMENT
Placebo + standard therapy
OTHER
Lead Sponsor
NTC srl
NCT06778213
NCT06922448
NCT04502966
Data Source & Attribution
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