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

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.