Completed

ELYARMullein, Thyme, Propolis Nasal Spray for Children with Acute Rhinitis

What is being tested

Elysium Naso Gola

+ Placebo

Dietary SupplementOther

Who is being recruted

From 4 to 14 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Interventional

Study Start: December 2023

See protocol details

Summary

Principal SponsorFederico II University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2023

Actual date on which the first participant was enrolled.

This clinical study focuses on children suffering from acute rhinitis, a common condition that causes nasal discomfort and often affects children's quality of life. The condition, mainly caused by viral infections, is prevalent in kids, especially in the first years of school, and typically worsens during autumn and winter. Traditional treatments aim to relieve symptoms like nasal congestion and discomfort, but this study explores a new approach. It investigates a nasal spray made from natural ingredients like mullein, thyme, propolis, and long-chain polyphosphates, which are believed to help reduce inflammation, improve nasal passage function, and even combat viruses like Rhinovirus and SARS-CoV-2. Participants in this study will use the nasal spray containing these natural ingredients to see if it improves their symptoms. The study aims to determine the spray's effectiveness by observing changes in nasal congestion, inflammation, and overall respiratory health. This treatment is applied directly to the nasal passages, where it can work on the affected area. Researchers hope to demonstrate not only relief from symptoms but also a reduction in viral activity, potentially offering a more comprehensive treatment option for children with acute rhinitis.

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

NCT06757179

Principal SponsorFederico II University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 4 to 14 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate

Caucasian subjects of both sexes,

aged between 4 and 14 years;

in addition to ≥1 of the following signs/symptoms: headache;

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;

Show More Criteria

4 exclusion criteria prevent from participating

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Roberto Berni Canani

Naples, ItalyOpen Roberto Berni Canani in Google Maps

CompletedOne Study Center