NCT06757179

The ELYAR (Elysium Against Rhinitis) Project

Evaluation of the Therapeutic Effect of a Formulation Based on Mullein, Thyme, Propolis, and Long-Chain Polyphosphates in Children Diagnosed with Acute Rhinitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 4 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

Acute rhinitis is an inflammatory process that primarily affects the nasal mucosa, with a high incidence in the pediatric population and a morbidity rate of 6-8 episodes annually during the first two years of schooling (1). It is one of the most common conditions causing discomfort and debilitation in children, compromising their quality of life, negatively affecting social interactions, school performance, and sleep quality. In most cases, the origin is viral and the course is seasonal, with higher incidence in the autumn and winter seasons (1). More than 100 viral strains are known to be responsible for this condition, among which Rhinoviruses are considered the most widespread and contagious (2). Symptoms, which typically begin 1-2 days after infection, include nasal congestion, nasal breathing obstruction, rhinorrhea, sneezing, coughing, headache, malaise, and sometimes mild fever, with complete remission generally occurring within 8-10 days (2). The therapeutic approach is exclusively symptomatic, mainly aimed at reducing nasal obstruction. Literature indicates that nasal irrigation with saline solution is the most useful treatment for cleansing the nasal passages, thinning nasal secretions, and allowing for easier elimination; in the presence of fever, antipyretics may be useful (3). Given these premises, the aim of this clinical study was to evaluate the therapeutic efficacy of an isotonic saline solution containing mullein, thyme, propolis, and long-chain polyphosphates, which are known for their natural properties to promote nasal secretion fluidity, reduce inflammation, and improve the functionality of the upper respiratory mucosa (4). In addition, more recent pre-clinical data suggested that this formulation exerts an antiviral action characterized by inhibition of virus replication (Rhinovirus and SARS-CoV-2) and an anti-inflammatory action through modulation of NF-Kb signaling in cultured human nasal respiratory epithelial cells. These effects are also associated with antibacterial action thanks to mullein and thyme.

Conditions

• Rhinitis Viral

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Elysium Naso Gola	Elysium Naso Gola Supplement is a dietary supplement designed to soothe the upper respiratory tract, providing a range of benefits thanks to the properties of its natural ingredients. Its anti-inflammatory, antibacterial, antifungal, antiviral, antioxidant, and prebiotic activities suggest a comprehensive product for supporting respiratory health. Mullein promotes the functionality of the respiratory mucous membranes. Thyme supports nasal and throat well-being, aids in the fluidity of bronchial secretions, and has antioxidant properties.
OTHER	Placebo	Placebo

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-07-01
• Completion: 2024-07-31
• First posted: 2025-01-03
• Last updated: 2025-01-03

Locations

1 site across 1 country: Italy