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Study on the Effectiveness of Elixirium Thymi Compositum for Treating Acute Bronchitis in Children

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of acute bronchitis in children. Acute bronchitis is a condition where the airways in the lungs become inflamed, often leading to coughing and difficulty breathing. The study will use a treatment called Elixirium thymi compositum, which is an oral solution containing a liquid extract of thyme. Thyme is a herb that has been traditionally used for its potential health benefits, including easing coughs and respiratory issues.

The purpose of this study is to evaluate how effective and safe Elixirium thymi compositum is in treating acute bronchitis in children. The study will also aim to reduce the unnecessary use of antibiotics in treating this condition. Participants in the study will receive either the thyme extract solution or a placebo, and neither the participants nor the researchers will know who receives which treatment. This is known as a double-blind study, which helps ensure the results are unbiased.

The study will take place over a period of time, during which the children will be monitored for changes in their symptoms and any side effects. The main focus will be on how well the treatment works in reducing the severity of bronchitis symptoms, as measured by a specific scoring system. Additionally, the safety of the treatment will be assessed by tracking any adverse events reported by the participants. The study aims to provide valuable information on the use of herbal treatments for respiratory conditions in children.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be randomly assigned to receive either the investigational product, Elixirium thymi compositum, or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives which treatment.
Step 2
Medication administration
Participants will take the assigned oral solution as directed. The solution is to be taken by mouth. The dosage, frequency, and duration of administration will be provided by the study team and must be followed precisely.
Step 3
Monitoring and assessments
Throughout the study, participants will be monitored for changes in their condition. The primary focus will be on the Bronchitis Severity Score (BSS), which measures the severity of acute bronchitis symptoms.
Participants will also be observed for any side effects or adverse events to assess the safety and tolerability of the treatment.
Step 4
Completion of the study
At the end of the study period, participants will undergo a final assessment to evaluate the overall effectiveness of the treatment. This will include a review of the BSS and any reported side effects.
The study is expected to conclude by March 31, 2026.

Who can join the trial?

4 criteria

Participants must be children aged between 6 and 17 years old.
Participants must have acute bronchitis, which is a sudden inflammation of the airways in the lungs.
Participants must have a BSS score (Bronchitis Severity Score) between 5 and 12. This score is used to measure the severity of bronchitis symptoms.
Both boys and girls can participate in the study.

Who cannot join the trial?

7 criteria

Patients with any other respiratory illness besides acute bronchitis cannot participate. Acute bronchitis is a sudden inflammation of the airways in the lungs.
Patients who are currently taking antibiotics for any reason are not eligible.
Patients with a known allergy to any of the ingredients in the study medication cannot join.
Patients with a history of severe allergic reactions to medications are excluded.
Patients with any chronic illness that requires regular medication are not eligible.
Patients who have participated in another clinical trial within the last 30 days cannot take part.
Patients who are unable to follow the study procedures or attend the required visits are not eligible.

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Investigated drugs

Elixirium thymi compositum is a medication being tested in this clinical trial to see how well it works in treating acute bronchitis in children. This medicine is made from a combination of natural ingredients, including thyme, which is known for its potential to help with respiratory issues. The goal of using this medication is to help reduce symptoms like coughing and difficulty breathing, which are common in bronchitis. By using this treatment, the trial also aims to reduce the need for antibiotics, which are often used inappropriately for this condition. The study will evaluate both the effectiveness and safety of this medication in young patients.

LIQUID EXTRACT OF THYME (1:3.45-3.85), EXTRACTION SOLVENT: ETHANOL 27%(V/V)

What is already known about the treatment

Elixirium thymi compositum – This medication is administered orally in the form of a liquid elixir. It is currently being studied in a phase 4 clinical trial to assess its effectiveness in treating acute bronchitis in children, with the aim of reducing unnecessary antibiotic use. The main therapeutic indication for Elixirium thymi compositum is acute bronchitis, a condition characterized by inflammation of the bronchial tubes in the lungs. At the molecular level, the medication is believed to work by soothing the airways and reducing inflammation, although the exact mechanism is still under investigation. It is classified pharmacologically as a herbal remedy, utilizing natural plant extracts to achieve its therapeutic effects.

Investigated diseases

Acute bronchitis – Acute bronchitis is an inflammation of the bronchial tubes, which are the air passages that extend from the windpipe into the lungs. It typically begins with a cough that may produce mucus, and it often follows a respiratory infection such as a cold. The condition can cause symptoms like chest discomfort, fatigue, and a slight fever. As the disease progresses, the cough may become more persistent and can last for several weeks. The inflammation leads to swelling and increased mucus production, which can make breathing more difficult. The condition is usually self-limiting, resolving as the inflammation decreases.