Trial To Assess Efficacy and Safety of PediaFlu® in Children With Acute Tonsillopharyngitis / Rhinopharyngitis

NACompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

June 3, 2021

Primary Completion Date

August 12, 2021

Study Completion Date

August 12, 2021

Conditions
TonsillopharyngitisRhinopharyngitis
Interventions
DIETARY_SUPPLEMENT

Standard of care + PediaFlù®

Standard of care: Standard of care for acute tonsillitis / rhinopharyngitis is focused on symptomatic treatment. PediaFlù®: During the 6 days of the clinical investigation, the subjects will administer PediaFlù® 5ml x3 times per day for children below 6 years and 10mlx3 times per day for children above 6 years.

OTHER

Standard of care

Standard of care for acute tonsillitis / rhinopharyngitis is focused on symptomatic treatment. Standard of care Nasopharyngeal liberation through hydration with drinking fluids to support body fluid excretion, aspiration of secretions, NaCl solution for nasal irrigation, Nasal sprays with sea water, nasal spray with active compound (to be used only at special indication of the medical doctor) Throat spray with Benzydamine hydrochloride (Tantum Verde®), Pediatric use: children over 6 and below 12: 4 sprays 2 - 6 times a day. Children (under 6 years): 1 spray per 4 kg of body weight, a maximum of 4 sprays at once, 2-6 times a day according to the leaflet. Each spray equals 0.17 ml of solution. Acetaminophen (Paracetamol) per os: at need, as antipyretic (\>38,5C), 10 mg/kg/dose, per need every 6-8 hours or according to the leaflet, maximum dosage 80 mg / kg / day. A dosage of over 30 mg/Kg/dose will result in an IP failure;

Trial Locations (3)

300210

CMMF Dr. Morariu Bordea Maria, Timișoara

300288

CM Dr. Herteg Dorina, Timișoara

Unknown

CM Dr. Matei Cristian-Radu, Timișoara

All Listed Sponsors
collaborator

Opera CRO, a TIGERMED Group Company

OTHER

lead

Pediatrica S.r.l

OTHER