Rhinitis ViralELYARNCT06757179

The ELYAR (Elysium Against Rhinitis) Project

A study testing Elysium Naso Gola in people with Rhinitis Viral, run by Federico II University at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 4 to 14 years
Conditions the study is for: Rhinitis Viral
What is being tested?: Elysium Naso Gola
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteItaly
Study dates: 1 Dec 2023to 31 Jul 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Roberto Berni Canani
Naples

Other trials in Italy

About this study

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

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
Being tested: Elysium Naso Gola, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Elysium Naso GolaDietary 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.
PlaceboOther
Placebo

Study groups in NCT06757179
Study group	Role	What they receive
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. Receives: Dietary Supplement: Elysium Naso Gola
Placebo	Placebo comparator	Placebo Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: after 5 days of treatment

Secondary outcomes (2)

nasal obstruction - score of Visual Analog scale
Secondary endpoints were the evaluation of the therapeutic efficacy of "Elysium Naso-gola" in reducing nasal obstruction in children with acute rhinitis after 5 days of treatment using the Visual Analog scale (VAS) . The VAS for nasal obstruction was graded from 0 to 10 mm, where 0 corresponded to "no obstruction" and 10 corresponded to "complete obstruction" (converted from 0 to 100% obstruction).
Measured: after 5 days of treatment
complete resolution of acute rhinitis symptoms
the evaluation of the therapeutic efficacy of "Elysium Naso-gola" on the total complete resolution of acute rhinitis symptoms after 10 days.
Measured: after 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202331 Jul 2024

First posted3 Jan 2025
Study start1 Dec 2023
Primary completion1 Jul 2024
Study completion31 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rhinitis ViralStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06757179
Sponsor's protocol ID: 178/23
Acronym: ELYAR
Status last verified: Jan 2025
First submitted: 23 Dec 2024
Last updated: 3 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Longitudinal Deep Phenotyping of Central Mechanisms in Dysosmia: A Pilot Study Using Electrobulbogram (EBG), Functional MRI (fMRI), and Diffusion-Weighted Imaging (DWI)
Respiratory Tract Infection, Smell Disorder
Recruiting
RhinAV_Evaluation of Treatments for Acute Viral Rhinitis, Rhinosinusitis, and Rhinopharyngitis
Rhinitis Acute, Rhinitis Viral
Recruiting
Impact of a Multimodal Intervention on Antibiotic Prescribing for Respiratory Infections in Primary Care
Angina, Acute Bronchiolitis
Recruiting
Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
URTI, Bronchiolitis
RecruitingPhase 2
Viral Mucosal Reprogramming
Asthma, Allergic Rhinitis

All Rhinitis Viral trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Therapeutic Effect of a Formulation Based on Mullein, Thyme, Propolis, and Long-Chain Polyphosphates in Children Diagnosed with Acute Rhinitis
ClinicalTrials.gov ID: NCT06757179
Acronym / sponsor ID: ELYAR / 178/23
Conditions: Rhinitis Viral
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Federico II UniversityUniversity, hospital or other
Study start: 1 Dec 2023 (actual)
Primary completion: 1 Jul 2024 (actual)
Study completion: 31 Jul 2024 (actual)
First posted: 3 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Supplement	Experimental	Dietary Supplement: Elysium Naso GolaElysium 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.
Placebo	Placebo comparator	Other: PlaceboPlacebo

Who may qualify

Ages: 4 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Elysium Naso GolaElysium 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	Supplement
PlaceboPlacebo	Other	Placebo

Primary outcome

severity of symptoms - score of Italian Nasal Obstruction Symptom Evaluation
Time frame: after 5 days of treatment
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).

2 secondary outcomes

nasal obstruction - score of Visual Analog scale
Time frame: after 5 days of treatment
complete resolution of acute rhinitis symptoms
Time frame: after 10 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
Individual participant dataSharing planned: Undecided

Related trials for Rhinitis Viral

RecruitingObservational study
Longitudinal Deep Phenotyping of Central Mechanisms in Dysosmia: A Pilot Study Using Electrobulbogram (EBG), Functional MRI (fMRI), and Diffusion-Weighted Imaging (DWI)
Respiratory Tract Infection, Smell Disorder
Recruiting
RhinAV_Evaluation of Treatments for Acute Viral Rhinitis, Rhinosinusitis, and Rhinopharyngitis
Rhinitis Acute, Rhinitis Viral
Recruiting
Impact of a Multimodal Intervention on Antibiotic Prescribing for Respiratory Infections in Primary Care
Angina, Acute Bronchiolitis
Recruiting
Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
URTI, Bronchiolitis
RecruitingPhase 2
Viral Mucosal Reprogramming
Asthma, Allergic Rhinitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Elysium Naso Gola in people with Rhinitis Viral, run by Federico II University at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

severity of symptoms - score of Italian Nasal Obstruction Symptom Evaluation (time frame: after 5 days of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06757179.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.