The ELYAR (Elysium Against Rhinitis) Project

NCT06757179 | Completed

• 1 other identifier: 178/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• severity of symptoms - score of Italian Nasal Obstruction Symptom Evaluation

  The primary endpoint was to assess the therapeutic efficacy of "Elysium Naso-gola" in reducing the severity of symptoms in children with acute rhinitis after 5 days of treatment with the Italian Nasal Obstruction Symptom Evaluation (I-NOSE questionnaire). A validated closed-question questionnaire with 5 items was administered to each enrolled subject to evaluate acute rhinitis symptoms. Each question was scored from 0 to 4 (0 = no problem; 4 = severe problem). The total score was multiplied by 5 to obtain the NOSE score, which classified the severity of nasal obstruction symptoms as follows: mild (5-25 points), moderate (30-50 points), severe (55-75 points), extreme (80-100 points).

  after 5 days of treatment

Secondary Outcomes (2)

• nasal obstruction - score of Visual Analog scale

  after 5 days of treatment

• complete resolution of acute rhinitis symptoms

  after 10 days

Study Arms (2)

Supplement

EXPERIMENTAL

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.

Dietary Supplement: Elysium Naso Gola

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Elysium Naso Gola DIETARY_SUPPLEMENT

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.

Supplement

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Caucasian subjects of both sexes,
• aged between 4 and 14 years;
• diagnosis of acute rhinitis based on the presence of ≥3 of the following symptoms that had onset within the last 24 hours: rhinorrhea, nasal congestion, nasal obstruction, sneezing, pharyngodynia, cough;
• in addition to ≥1 of the following signs/symptoms: headache;
• fever; malaise; burning eyes; myalgia;
• written informed consent obtained from the parents of the participants and from the participants themselves if older than 6 years.

You may not qualify if:

• non-Caucasian ethnicity; age \<4 and \>14 years; known hypersensitivity/allergy to any component of the dietary supplement;
• previous diagnosis of severe nasal septal deviation or any other condition that could cause nasal obstruction, such as nasal polyps;
• history of nasal or sinus surgery that could affect symptom scores; use of antibiotics, corticosteroids, or antihistamines within 2 weeks prior to the study; participation in other studies;
• conditions that made compliance with the protocol unlikely.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Roberto Berni Canani

Naples, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, PhD, Principal Investigator

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 3, 2025
• Study Start: December 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 31, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Locations

IT (1)