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

NACompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

September 15, 2017

Primary Completion Date

July 4, 2018

Study Completion Date

November 13, 2018

Conditions
Allergic Rhinoconjunctivitis
Interventions
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"

Trial Locations (17)

16132

Istituto Giannina Gaslini, Genova

20042

P.O. G. Salvini di Garbagnate Milanese - ASST Rhodense, Garbagnate Milanese

20099

Ospedale Città di Sesto San Giovanni - ASST Nord Milano, Sesto San Giovanni

20122

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan

20157

Ospedale San Carlo Borromeo - ASST Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo, Milan

20162

Ospedale Civile di Legnano - ASST Ovest Milanese, Legnano

21051

P.O. di Busto Arsizio - ASST Valle Olona, Busto Arsizio

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

67100

Ospedale regionale San Salvatore - ASL 1 Avezzano Sulmona L'Aquila, L’Aquila

70126

"A.O.U. Consorziale Policlinico Giovanni XXIII", Bari

"A.O.U. Consorziale Policlinico-Giovanni XXIII", Bari

80138

"Az. Osp. Univ. dell'Università degli Studi della Campania Luigi Vanvitelli", Napoli

88900

P.O. San Giovanni di Dio - ASP di Crotone, Crotone

89024

"Ospedale di Polistena Santa Maria degli Ungheresi - ASP di Reggio Calabria", Polistena

95123

A.O.U. Policlinico Vittorio Emanuele, Catania

98124

"A.O.U. Policlinico G. Martino", Messina

00161

A.O.U. Policlinico Umberto I, Roma

All Listed Sponsors
lead

NTC srl

INDUSTRY

NCT03365648 - Efficacy and Safety of Lertal® as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics | Biotech Hunter | Biotech Hunter