Efficacy and Safety of Elixirium Thymi Compositum in Pediatric Acute Bronchitis: A Double-Blind, Randomized, Placebo-Controlled Phase 4 Trial

The primary objective of this study is to establish the role of **Elixirium thymi compositum** by evaluating its clinical efficacy and safety in the treatment of **acute bronchitis** in pediatric patients. This study aims to determine whether the use of Elixirium thymi compositum can effectively reduce the inappropriate use of antibiotics, which is clinically significant given the global concern over antibiotic resistance. The study is designed as a double-blind, randomized, placebo-controlled, phase 4 trial, ensuring rigorous assessment of the treatment's impact on the targeted condition.

The clinical trial focuses on evaluating the efficacy and safety of **Elixirium thymi compositum** in treating **acute bronchitis** in children, aiming to reduce the inappropriate use of antibiotics. The study population comprises both male and female children aged 6 to 17 years, who are experiencing acute bronchitis with a Bronchitis Severity Score (BSS) between 5 and 12. The trial includes a vulnerable population, as it involves children. The sponsor has not provided information regarding the total number of participants. Participants were selected based on specific inclusion criteria, ensuring they meet the age and health condition requirements. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the efficacy and safety of **Elixirium thymi compositum** in treating **acute bronchitis** in pediatric patients. This study is a double-blind, randomized, placebo-controlled, phase 4 trial. The trial aims to establish the role of the investigational product by assessing its clinical efficacy and safety, while also aiming to reduce the inappropriate use of antibiotics in children. The trial is expected to commence on March 3, 2025, and conclude by March 31, 2026, with an estimated duration of one year.

Participants will be randomly assigned to receive either the investigational product, **Elixirium thymi compositum FoNo VIII. Naturland belsőleges oldat**, or a placebo. The investigational product is administered as an oral solution, with a maximum daily dose of 30 ml and a total maximum dose of 150 ml over a treatment period of 5 days. The primary endpoint of the study is the efficacy of the investigational product based on the Bronchitis Severity Score (BSS), while secondary endpoints include safety and tolerability as determined by reported adverse events.

The study will include children aged 6 to 17 years with acute bronchitis and a BSS score between 5 and 12. The sequence of study visits includes an initial screening visit to confirm eligibility, followed by treatment visits during the 5-day treatment period, and subsequent follow-up visits to monitor outcomes and adverse events. The end-of-study visit will assess the overall efficacy and safety of the treatment. Participant involvement is expected to last for the duration of the treatment period and follow-up visits, with conditions for early termination including withdrawal of consent or the occurrence of significant adverse events.

The clinical trial involves the administration of **Elixirium thymi compositum FoNo VIII. Naturland belsőleges oldat**, an **oral solution** containing a **liquid extract of thyme** (1:3.45-3.85) with **ethanol 27% (v/v)** as the extraction solvent. This experimental medication is intended for the treatment of **acute bronchitis** in pediatric patients. The maximum daily dose is 30 ml, with a total maximum dose of 150 ml over a treatment period of up to 5 days. The solution is administered orally, and participant compliance is monitored throughout the study to ensure adherence to the dosing schedule.

The study also includes a **placebo** group, which receives **Elixirium thymi compositum (fono viii.) placebo**. The placebo is designed to match the experimental medication in appearance and administration route but does not contain the active substance. This double-blind, randomized, placebo-controlled design allows for the assessment of the clinical efficacy and safety of the experimental treatment while minimizing bias. The placebo is administered in the same oral solution form and follows the same dosing schedule as the active treatment to maintain consistency across the study groups.

The efficacy of Elixirium thymi compositum in the treatment of acute bronchitis in pediatric patients will be assessed using the **Bronchitis Severity Score (BSS)** as the primary endpoint. This double-blind, randomized, placebo-controlled, phase 4 study aims to establish the clinical efficacy and safety of the investigational product while reducing the inappropriate use of antibiotics in children aged 6 to 17 years. The BSS, a validated scale, will be utilized to measure symptom improvement in participants with a baseline score between 5 and 12. The efficacy assessments will be conducted at specified intervals throughout the trial to monitor changes in the BSS, providing a quantitative measure of the investigational product's impact on acute bronchitis symptoms.