Therapeutic Efficacy of an Isotonic Saline Solution Enriched with Mullein, Thyme, and Long-Chain Polyphosphates in Pediatric Acute Rhinitis: A Randomized Controlled Trial

Abstract

Background and aim. Acute rhinitis (AR) is a common condition in children, primarily of viral origin, causing nasal congestion, rhinorrhea, and discomfort, with a significant impact on quality of life and economic burden. Current treatments are limited to symptomatic relief, with nasal irrigation being the primary non-pharmacological intervention. This study aimed at evaluating the efficacy and safety of Elysium Naso-gola—an isotonic saline solution enriched with mullein (Verbascum thapsus), thyme (Thymus vulgaris), propolis, and long-chain polyphosphates—in reducing symptom severity and duration in pediatric AR. Methods. A randomized, double-blind, placebo-controlled pilot trial was conducted on 60 children (aged 4–14 years) with AR. Participants were randomized into two groups: the active group received Elysium Naso-gola, while the placebo group received a sterile isotonic saline solution, both administered as nasal sprays four times daily for seven days. Symptom severity was assessed at baseline (T0), day 5 (T1), and day 10 (T2) using the I-NOSE questionnaire and Visual Analog Scale (VAS). The primary outcome was symptom reduction at T1, while secondary outcomes included nasal obstruction improvement and complete symptom resolution at T2. Results. At baseline, both groups exhibited comparable symptoms severity. At T1, the active group showed a significant reduction in I-NOSE scores compared to placebo group (p < 0.05), with a marked decrease in nasal obstruction severity. VAS scores also indicated a greater improvement in nasal breathing in the active group. At T2, complete symptom resolution was achieved in 60% of patients treated with Elysium Naso-gola, compared to only 5.3% in the placebo group (p < 0.01). No adverse events were reported, and treatment adherence was high in both groups. Conclusions. The findings suggest that Elysium Naso-gola is a safe and effective non-pharmacological treatment for pediatric AR, providing faster symptom relief and higher resolution rates. Larger multicenter trials are warranted to confirm these preliminary results and further explore its role in pediatric respiratory care.

1. Introduction

Acute rhinitis (AR) is a common condition in the pediatric age, particularly during the early years of schooling, when the incidence reaches up to six to eight episodes yearly [1]. Studies from Europe and North America estimate that the average child experiences between four and seven episodes per year, with the highest incidence occurring in daycare settings [2]. This inflammation of the nasal mucosa is predominantly of viral origin, with a seasonal trend that peaks in autumn and winter [3]. The primary causative agents are rhinoviruses, which account for the majority of cases due to their high transmissibility and diversity, with over 100 serotypes identified [4]. 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 [4]. Furthermore, AR is associated with substantial economic costs, including direct medical expenses and indirect costs due to caregiver absenteeism and productivity loss, which amount to billions of dollars annually in high-income countries [3,5]. AR has significant implications for pediatric health, adversely affecting quality of life, school performance, and sleep [6]. A quality-of-life survey among caregivers of children with recurrent AR highlighted increased stress levels and disruptions in family routines, emphasizing the broader impact of this condition [7]. Moreover, the inflammatory process triggered by viral infections can predispose children to secondary complications, such as otitis media and sinusitis [8].

The symptomatic management of AR remains the cornerstone of treatment. Current guidelines emphasize the importance of nasal irrigation with saline solutions to alleviate nasal obstruction, facilitate the clearance of mucus, and reduce the overall symptom burden [9,10]. Although antipyretics are frequently employed to manage fever associated with viral infections, the therapeutic strategies for this condition are otherwise limited [9,10].

There is growing interest in exploring non-pharmacological interventions that combine safety and efficacy, particularly in pediatric populations where medication use often necessitates caution. In this context, the role of natural compounds with antiviral, anti-inflammatory, and mucosal protective properties is gaining attention. For example, Mullein (Verbascum thapsus) and thyme (Thymus vulgaris) are traditional remedies with demonstrated antimicrobial, anti-inflammatory, and mucolytic properties [11,12,13,14]. Propolis, a resinous substance produced by bees, exhibits antiviral and anti-inflammatory effects through its polyphenol content, which modulates immune responses and inhibits viral replication [15,16,17]. Additionally, long-chain polyphosphates have been shown to enhance mucosal barrier integrity and exhibit antimicrobial properties, making them promising adjuncts in managing upper respiratory infections [18,19]. In this regard, medium- to long-chain polyphosphates (Pi ×40–120 in length) exhibit cytoprotective and antiviral activities against SARS-CoV-2 infection in various in vitro cellular models [20,21]. These effects are primarily achieved by enhancing the proteasome-mediated degradation of the host receptor ACE2 and the viral RdRp protein, inhibiting the interaction between the viral Spike protein and ACE2, and modulating inflammatory NF-κB signaling [20,21]. Consequently, this leads to a reduction in the levels of SARS-CoV-2 structural subgenomic RNAs (sgRNAs) and proteins [22], including sgN [23]. Furthermore, medium- to long-chain polyphosphates biopolymers have been also reported with antimicrobial activities via coacervation related process [19].

Recent advances have also shed light on the antiviral potential of these compounds against rhinoviruses and emerging viral pathogens like SARS-CoV-2. Preclinical studies suggest that formulations incorporating mullein, thyme, propolis, and medium- to long-chain polyphosphates can synergistically reduce the in vitro replication of SARS-CoV-2, respiratory syncytial virus (RSV), and influenza virus, with this effect primarily achieved through the modulation of inflammatory cytokines and chemokines, thereby activating the innate immune response [24]. These findings underscore the potential of such formulations not only to alleviate symptoms but also to target the underlying pathophysiological mechanisms of AR.

Building on this evidence, the present study evaluated the therapeutic efficacy of an isotonic saline solution enriched with mullein, thyme, propolis, and long-chain polyphosphates, marketed in Italy as “Elysium Naso-gola”. This pilot, randomized, double-blind, placebo-controlled trial aimed to provide preliminary data on the formulation’s ability to reduce the severity and duration of symptoms in children with AR. By addressing both symptom management and underlying inflammation, this approach seeks to fill a critical gap in the current treatment landscape for pediatric AR.

2. Methods

2.1. Study Design and Study Population

This study was a single-center, non-pharmacological interventional pilot trial, randomized with a placebo group. This study included Caucasian children of both sexes, aged 4 to 14 years, presenting with AR symptoms within 24 h prior to enrollment. Subjects were recruited from the Pediatric Specialist Outpatients Clinic at the Pediatric Section of Integrated Maternal and Child Care Department, University of Naples “Federico II”.

Inclusion criteria required subjects to exhibit ≥3 AR symptoms (e.g., rhinorrhea, nasal congestion, nasal obstruction, sneezing, pharyngodynia, cough) within the last 24 h, along with ≥1 associated symptom (e.g., headache, fever, malaise, burning eyes, myalgia). Written informed consent was obtained from parents or legal guardians, and children aged >6 years provided assent.

Exclusion criteria included non-Caucasian ethnicity; age < 4 or >14 years; known hypersensitivity to the dietary supplement components; prior diagnoses of severe nasal septal deviation, nasal polyps, or other conditions causing nasal obstruction; history of nasal or sinus surgery affecting symptom scoring; recent use of antibiotics, corticosteroids, or antihistamines (within 2 weeks); participation in other studies; or conditions compromising protocol adherence.

2.2. Ethics

The study protocol, patient information sheet, informed consent form, and clinical chart were reviewed and approved by the Ethical Committee of the University of Naples Federico II. This study adhered to the Helsinki Declaration (Fortaleza revision, 2013), Good Clinical Practice standards (CPMP/ICH/135/95), and relevant European and Italian data protection regulations. This study was registered on ClinicalTrials.gov with the identifier NCT06757179.

2.3. Data Collection

During the initial visit (Enrollment, Visit 1, T0), experienced pediatricians evaluated each subject for eligibility. Demographic and medical history data were collected, and the diagnosis of AR was confirmed. After obtaining informed consent from parents or legal guardians, participants completed two key assessment tools. The I-NOSE Questionnaire, a validated instrument designed to measure AR symptoms, consisted of five closed-ended questions [25,26]. Each item was rated on a scale from 0, indicating no problem, to 4, representing a severe problem. The total score was then multiplied by 5 to classify the severity of nasal obstruction. Additionally, the Visual Analog Scale (VAS) questionnaire was used as a psychometric measurement tool to document the severity and characteristics of disease-related symptoms [25,26,27]. This tool allowed for a rapid, statistically measurable, and reproducible classification of symptom severity and disease control. As in the original study, the criterion validity was assessed by comparing the I-NOSE scale items with the VAS, which measured the subjective perception of nasal obstruction. The VAS for nasal obstruction ranged from 0 to 10 mm, where 0 indicated no obstruction and 10 represented complete obstruction, corresponding to a conversion from 0 to 100% obstruction.

During the treatment phase (Day 1–7), participants were randomized in a 1:1 ratio into two groups. “Active” group received four sprays of “Elysium Naso-gola” in each nostril every six hours for seven days, while “Placebo” group was administered four sprays of a sterile isotonic saline solution (placebo) following the same dosage regimen.

Product “Elysium Naso-gola” was approved by Italian Minister of Health as dietary supplement (MINSAN code: 987686375). Only a single batch of both active and placebo were used in the whole study. Both the active product and placebo were identical in appearance, taste, and smell, ensuring double-blind conditions. Parents were provided with detailed instructions for administration and adherence monitoring.

During the follow-up visits, physicians conducted assessments at two key time points. On Day 5 (Visit 2, T1), they reassessed symptom severity using the I-NOSE questionnaire and VAS, monitored treatment adherence, and documented any adverse events. On Day 10 (Visit 3, T2), a final clinical evaluation was performed to determine whether symptoms had fully resolved.

2.4. Data Entry

Data were recorded anonymously in case report forms (CRFs). Completeness and accuracy were verified by two researchers. Data were entered into a secure database and reviewed by a biostatistician for data cleaning and analysis before database locking.

2.5. Study Outcomes

The primary objective of this study was to evaluate the therapeutic efficacy of “Elysium Naso-gola” in alleviating symptom severity in children with AR after five days of treatment, as assessed using the I-NOSE questionnaire. Additionally, secondary outcomes aimed to examine Elysium Naso-gola’s effectiveness in reducing nasal obstruction over the same period, measured through the VAS scale, and to assess its role in achieving complete resolution of AR symptoms. Additionally, secondary outcomes aimed to examine “Elysium Naso-gola” effectiveness in reducing nasal obstruction over the same period, measured through the VAS scale, and to assess its role in achieving complete resolution of AR symptoms by day 10 (three days after completing the 7-day treatment course).

2.6. Sample Size

Given the novelty of the product and the lack of prior clinical data, this study was designed as a pilot. A total of 60 participants, with 30 allocated to each group, was considered adequate to generate meaningful preliminary evaluations while ensuring a balance between data reliability and ethical considerations.

2.7. Statistical Analysis

The Kolmogorov–Smirnov test assessed the normality of variable distributions. Normally distributed variables were expressed as means ± standard deviations, while non-normally distributed continuous variables were reported as medians and interquartile ranges. Categorical variables were analyzed using the χ² test.

Primary outcome analysis (symptom severity with the I-NOSE questionnaire) involved mean comparisons between groups at each time point using the t-test. The severity distribution of nasal obstruction was analyzed using the χ² test.

Secondary outcome analysis (nasal obstruction with the VAS scale and complete resolution of symptoms) involved t-tests for mean comparisons and χ² tests for resolution rates. In addition, a multivariable linear regression analysis was performed to evaluate whether potential confounding variables—such as exposure to passive smoking, exposure to pets, urban setting, damp housing, breastfeeding, and number of respiratory infections per year—were associated with changes in NOSE scores (ΔNOSE score) from baseline to T1. The analysis was conducted both in the overall population and within each treatment group. All statistical tests were two-tailed, with a significance level of p < 0.05. Data analysis was conducted using SPSS 23.0 (IBM Corporation, Armonk, NY, USA).

3. Results

3.1. Study Population

Seventy-five consecutive subjects were evaluated for this study. Of these, 15 subjects were excluded due to the presence of exclusion criteria: 7 had recently used antibiotics, 5 had recently taken corticosteroids or antihistamines, 1 presented with nasal polyps, 1 had a nasal septal deviation, and 1 was participating in another clinical study. Consequently, a total of 60 patients were enrolled, evenly distributed between the two study groups (30 subjects per group).

Table 1. Baseline features of the enrolled children.

	PLACEBO	ACTIVE
	N = 30	N = 30
Male sex	16 (53.3%)	14 (46.7%)
Age (months, ±SD)	109.8 (31.9)	99.8 (34.4)
Cesarean delivery	10 (33.3%)	9 (30%)
Born at term	30 (100%)	30 (100%)
Birth weight (kg, ±SD)	3.5 (0.3)	3.6 (0.4)
Breastfed for at least 2 months	27 (90%)	23 (76.7%)
Siblings (IQR)	1 (0)	1 (0)
Familial risk of allergy	9 (30%)	14 (46.7%)
Allergy in the first-degree relatives	1 (1)	1 (1)
Exposed to passive smoking	10 (33.3%)	15 (50%)
Exposed to pets	10 (33.3%)	10 (33.3%)
Urban setting	26 (86.7%)	27 (90%)
Damp housing	0	3 (10%)
Weight at enrolment (kg, ±SD)	36.2 (12.2)	35.1 (14.1)
Height at enrolment (m, ±SD)	1.35 (0.18)	1.31 (0.17)
Body mass index at enrolment (±SD)	19.19 (2.78)	19.73 (4.7)

Continuous variables are reported as mean (± standard deviation) or median (and interquartile range). Discrete variables are reported as the number and proportion of subjects with the characteristic of interest.

summarizes the main demographic and clinical characteristics of the study population. Both groups were comparable in terms of baseline demographic and anamnestic features, ensuring homogeneity.

Table 2. Frequency and duration of respiratory infections and febrile episodes at baseline.

	PLACEBO	ACTIVE
	N = 30	N = 30
Number of respiratory infections per year
<3	2 (6.7%)	7 (23.3%)
3–6	24 (80%)	19 (63.3%)
>6	4 (13.3%)	3 (10%)
1 per month	0	1 (3.3%)
Number of respiratory infections between October–December and March–May
<3	22 (73.3%)	15 (50%)
3–6	8 (26.7%)	14 (46.7%)
1 per month	0	1 (3.3%)
Mean duration of each episode
<3	7 (23.3%)	9 (30%)
3–6	23 (76.7%)	19 (63.3%)
>6	0	2 (6.7%)
Number of febrile episodes per year
<3	3 (10%)	6 (20%)
3–6	20 (66.7%)	19 (63.3%)
>6	7 (23.3%)	5 (16.7%)

Discrete variables are reported as the number and proportion of subjects with the characteristic of interest.

details the baseline frequency and duration of respiratory infections and febrile episodes in the enrolled subjects. The majority of participants in both groups reported experiencing three to six respiratory infections annually, each lasting an average of 3 to 6 days. Similarly, over 60% of participants in both groups had between three and six febrile episodes per year.

3.2. Main Study Outcome

The primary outcome, represented by the total score of the I-NOSE questionnaire, is illustrated in Figure 1. At baseline (T0), both study groups demonstrated similar NOSE scores, reflecting comparable severity of nasal obstruction. However, after 5 days of treatment (T1), the NOSE scores were significantly lower in the group treated with the active product compared to the placebo group. Specifically, at T1 the mean NOSE score was 69.2 (95% CI: 64.8–73.5) in the placebo group and 26.7 (95% CI: 20.5–32.8) in the active treatment group, confirming a marked improvement in nasal obstruction symptoms. Additionally, a statistically significant reduction in NOSE scores was observed within the active group when comparing T0 to T1.

Supplementary Table S1 shows the distribution of the five individual items of the I-NOSE questionnaire across the study period. While no substantial changes were observed in the placebo group, the active group demonstrated a clear trend toward improvement, with responses shifting from “severe problem” and “quite significant problem” to “moderate problem”, “very mild problem”, and “no problem”.

Table 3. Distribution of severity of nasal obstruction symptoms during the study period in the two groups.

	PLACEBO	ACTIVE
	N = 30	N = 30
Severity of nasal obstruction at T0
Mild (5–25)	0	3 (10%)
Moderate (30–50)	1 (3.3%)	6 (20%)
Severe (55–75)	24 (80%)	13 (43.3%)
Extreme (80–100)	5 (16.7%)	8 (26.7%)
Severity of nasal obstruction at T1
Mild (5–25)	0	17 (56.7%)
Moderate (30–50)	1 (3.3%)	12 (40%)
Severe (55–75)	22 (73.3%)	1 (3.3%)
Extreme (80–100)	7 (23.3%)	0

Discrete variables are reported as the number and proportion of subjects with the characteristic of interest.

highlights the distribution of nasal obstruction severity throughout this study. In the placebo group, the proportions of subjects with moderate, severe, or extreme obstruction remained relatively unchanged between T0 and T1. Conversely, in the active group, the proportion of subjects with severe or extreme nasal obstruction decreased markedly, with a shift toward mild and moderate categories.

3.3. Secondary Outcomes

The secondary outcomes, assessed using the VAS scale, are presented in Figure 2. At enrollment, the two study groups had comparable VAS scores, indicating similar perceptions of nasal obstruction. After 5 days of treatment (T1), a significant reduction in VAS scores was observed in the active group, reflecting a notable improvement in the subjective sensation of nasal obstruction. At T1, the mean VAS score was 64.3 (95% CI: 58.4–70.3) in the placebo group and 40.0 (95% CI: 33.7–46.3) in the active treatment group, further supporting the efficacy of the active product in alleviating nasal symptoms. Statistically significant differences were noted between the groups at T1 and between T0 and T1 within the active group.

After 10 days from enrollment (T2), 60% of subjects in the active group achieved complete resolution of AR symptoms, compared to only 5.3% in the placebo group. This difference was statistically significant, underscoring the superior efficacy of the active product in resolving symptoms.

To explore potential confounding factors influencing the treatment response, a multivariable linear regression analysis was performed using the change in NOSE score (ΔNOSE sore) as the dependent variable. The independent variables included exposure to passive smoking, exposure to pets, urban setting, damp housing, breastfeeding, and the number of respiratory infections per year. The analysis revealed that none of these variables were significantly associated with the change in NOSE score, neither in the overall study population nor when stratified by treatment group. These findings suggest that the observed improvement in nasal obstruction symptoms was not influenced by these baseline characteristics.

3.4. Safety

No participant demonstrated intolerance to the study products. Furthermore, no adverse events were attributed to the active product or placebo, and adherence to the treatment protocol was consistent across both groups.

4. Discussion

The findings of this randomized controlled trial highlight the therapeutic efficacy of Elysium Naso-gola, an isotonic saline solution enriched with mullein (Verbascum thapsus), thyme (Thymus vulgaris), propolis, and long-chain polyphosphates, in the management of pediatric AR. The significant reduction in symptom severity, as assessed using the I-NOSE questionnaire and VAS scale, underscores the formulation’s potential as a safe and effective non-pharmacological intervention [26,27]. These results align with existing evidence supporting the use of conventional saline irrigation for reducing nasal congestion and improving mucociliary clearance in upper respiratory infections [9].

However, the enhanced efficacy observed in this study suggests that the additional bioactive compounds provide benefits beyond those of standard saline solutions. Thyme (Thymus vulgaris), a key component of Elysium Naso-gola, has demonstrated antimicrobial, mucolytic, and anti-inflammatory properties, which are beneficial for upper respiratory tract infections [11,12,28]. Essential oils derived from thyme have been shown to modulate pro-inflammatory cytokines and reduce bacterial and viral loads in respiratory infections [13]. Similarly, mullein (Verbascum thapsus) has been traditionally used for respiratory conditions due to its expectorant and anti-inflammatory effects [14]. A phytochemical study analyzed extracts of Verbascum thapsus, identifying the presence of saponins with expectorant properties that can help relieve symptoms in respiratory conditions [29].

Propolis, another active component, has been extensively studied for its antiviral, antibacterial, and immunomodulatory effects. Clinical and preclinical studies indicate that propolis extracts inhibit viral replication, modulate immune responses, and reduce inflammation, making it a promising adjunct for upper respiratory infections [15,16].

The inclusion of long-chain polyphosphates in this formulation represents an innovative aspect, as these compounds have been found to enhance mucosal barrier integrity, inhibit bacterial adhesion, and exert antimicrobial properties. Emerging evidence suggests that polyphosphates contribute to the protection of epithelial surfaces in the respiratory tract and could play a crucial role in reducing infection susceptibility [24].

The absence of adverse events in this study supports the safety of “Elysium Naso-gola”, which is consistent with the literature indicating that natural compounds are generally well tolerated and present minimal side effects compared to synthetic drugs [17]. Furthermore, the rapid symptom alleviation observed in the active treatment group suggests that this formulation could shorten the duration of illness, potentially mitigating the economic burden of AR, which includes direct healthcare costs and indirect losses due to caregiver absenteeism [3,5].

Despite the promising results, this study presents several limitations. Firstly, the relatively small sample size restricts the generalizability of our findings. Additionally, the short follow-up period of only 10 days does not permit drawing definitive conclusions regarding the long-term safety and efficacy of repeated treatment use. Given that AR can exhibit recurrence or rebound effects after therapy cessation, future research should adopt a longer observational period (e.g., 4–6 weeks) to accurately assess sustained therapeutic outcomes and potential delayed adverse effects.

Another limitation is the exclusive enrollment of Caucasian pediatric patients aged between 4 and 14 years. This demographic constraint limits the applicability of our results to other ethnic groups and broader pediatric age ranges, such as toddlers and adolescents. Variations in immune response, nasal physiology, and anatomical structures among diverse populations may significantly affect therapeutic efficacy and tolerability. Thus, future studies should recruit more diverse ethnic populations and include a wider pediatric age spectrum to enhance the findings’ external validity.

Moreover, this study was conducted in a single pediatric outpatient clinic, further limiting external validity. Factors such as environmental conditions, genetic predispositions, and healthcare practices may differ considerably across settings, influencing therapeutic outcomes. Therefore, subsequent research should involve larger, multicenter trials across diverse geographic regions to validate these preliminary findings and ensure broader generalizability and applicability.

Additionally, this study relied exclusively on subjective symptom-based assessments, such as the I-NOSE questionnaire and VAS, lacking objective biomarkers to elucidate underlying inflammatory or viral mechanisms associated with AR. Integrating objective measures like nasal swabs for viral detection, inflammatory cytokine profiling (e.g., IL-6, TNF-α), or systemic biomarkers such as C-reactive protein (CRP) would significantly enhance the mechanistic understanding of treatment effects. Future studies should therefore incorporate these objective assessments to complement clinical evaluations.

While our results support previously reported antimicrobial, mucolytic, and anti-inflammatory properties attributed to mullein, thyme, and polyphosphates, the present study does not offer detailed insights into the cellular and molecular pathways involved. Future research would greatly benefit from complementary in vitro or ex vivo investigations, particularly focusing on nasal epithelial cell responses. Studies examining changes in epithelial barrier integrity, mucus production, ciliary function, and inflammatory gene expression would enrich our understanding of the therapeutic mechanisms, strengthening the clinical evidence derived from current and subsequent clinical trials.

Additionally, our study compared the effectiveness of “Elysium Naso-gola” solely against placebo (standard isotonic saline solution), without incorporating active comparator groups representative of other established non-pharmacological therapies such as hypertonic saline nasal irrigation, steam inhalation methods, or honey-based treatments. Moreover, future studies should include head-to-head comparisons with conventional pharmacological treatments like antihistamines and nasal corticosteroids to clearly determine the relative efficacy, safety profile, and clinical positioning of “Elysium Naso-gola”. Such comparative studies would substantially enhance the therapeutic value and inform clinical decisions within pediatric AR management.

Finally, this pilot trial lacked qualitative data collection concerning patient experiences and caregiver satisfaction. Gathering subjective feedback through structured interviews, surveys, or open-ended questionnaires would significantly contribute to understanding treatment acceptability, perceived effectiveness, and practical implications for families. Future research should therefore incorporate qualitative methodologies to offer comprehensive insights into patient-centered outcomes, thus ensuring the broader relevance and applicability of “Elysium Naso-gola” in pediatric care.

The strengths of this study include its rigorous randomized, double-blind, placebo-controlled design, which minimizes bias and enhances the validity of the findings. The use of validated tools such as the I-NOSE questionnaire and VAS scale ensures robust assessment of symptom severity [25,26]. Moreover, the focus on a natural, well-tolerated formulation aligns with the increasing demand for safe and effective non-pharmacological treatments, particularly in pediatric care.

Compared to conventional saline solutions, “Elysium Naso-gola” offers additional therapeutic benefits. While standard saline irrigation primarily facilitates mechanical mucus clearance, the active ingredients in this formulation provide complementary anti-inflammatory, antiviral, and antimicrobial effects [18]. Thyme has been shown to improve mucosal function and reduce microbial colonization in the nasal passages, reinforcing its role in respiratory health [13].

Taken together, these findings highlight the potential of “Elysium Naso-gola” as an effective non-pharmacological treatment for AR in children. The significant reduction in symptom severity and duration, coupled with its excellent safety profile, positions this product as a promising alternative to conventional treatments. By addressing both symptomatic relief and underlying pathophysiological mechanisms, “Elysium Naso-gola” represents a holistic approach to managing pediatric AR.

Further large-scale studies are essential to confirm these results, elucidate the precise mechanisms of action, and explore its long-term benefits. Expanding research to adult populations and chronic conditions could further solidify its role in respiratory care [25]. If validated through broader clinical trials, “Elysium Naso-gola” could emerge as a valuable alternative to conventional treatments, offering a safe, effective, and natural approach to managing AR and reducing its socioeconomic impact.

Overall, the present study provides promising preliminary evidence supporting the use of “Elysium Naso-gola” as a potential non-pharmacological intervention for pediatric AR. Nevertheless, several methodological limitations must be carefully addressed in future studies. Specifically, larger, multicenter randomized controlled trials; incorporating longer follow-up periods; validation with objective biomarkers; and detailed mechanistic in vitro and ex vivo investigations will be crucial. Such comprehensive approaches are required to confirm and extend the current findings, to better understand the underlying therapeutic mechanisms, and to ultimately establish robust, evidence-based clinical recommendations for pediatric AR management.