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Study on the Effectiveness of Thyme Herb Extract, Primrose Root Tincture, and Ivy Leaf Extract for Patients with Acute Bronchitis

Verified siteRegistered drugNo placebo
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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, a condition where the airways in the lungs become inflamed, often leading to coughing and difficulty breathing. The study will compare the effectiveness and safety of three different herbal medicines. The first treatment is called Prospan® Hustentropfen, which contains a dry extract from ivy leaves. The second treatment is Bronchicum Tropfen, which includes a liquid extract from thyme herb and primrose root tincture. The third treatment is Bronchipret® Tropfen, which combines fluid extracts from thyme herb and ivy leaves.

The purpose of the study is to evaluate how well these treatments work in reducing the severity of symptoms in patients with acute bronchitis over a period of seven days. Participants will be randomly assigned to receive one of the three treatments or a placebo. The study will monitor changes in the severity of bronchitis symptoms using a scoring system known as the Bronchitis Severity Score (BSS).

Throughout the study, participants will take the assigned treatment orally, as all medications are in liquid form. The study will last for a total of seven days, during which participants will have several visits to assess their progress. The goal is to determine if the herbal treatments are as effective as each other in managing the symptoms of acute bronchitis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of acute bronchitis symptoms for 48-72 hours prior to treatment, ensuring the patient is between 18 and 75 years old, and confirming a good state of health aside from bronchitis.

    The assessment also involves measuring the Bronchitis Severity Score (BSS), which must be at least 10 points, and the Cough Severity (CS) score, which must be at least 50 mm on a visual scale.

  2. Step 2

    Treatment assignment

    Patients are randomly assigned to receive one of three herbal medicinal products: Bronchicum Tropfen, Bronchipret® Tropfen, or Prospan® Hustentropfen. All medications are administered as oral liquids.

  3. Step 3

    Medication administration

    The assigned medication is taken orally as per the study protocol. The specific dosage and frequency are determined by the study guidelines and are consistent throughout the trial period.

  4. Step 4

    Treatment duration

    The treatment lasts for 7 days. During this period, patients continue to take the assigned medication as instructed.

  5. Step 5

    Follow-up visits

    Patients attend follow-up visits on days 2, 3, 4, 5, 6, 7, and 8 after the initial visit. During these visits, the Bronchitis Severity Score (BSS) and Cough Severity (CS) are reassessed to monitor changes and evaluate the effectiveness of the treatment.

  6. Step 6

    Final assessment

    At the end of the treatment period, a final assessment is conducted to determine the overall change in the Bronchitis Severity Score (BSS) and Cough Severity (CS). This helps in evaluating the efficacy and safety of the herbal medicinal products.

Who can join the trial?

9 criteria

  • Have **acute bronchitis** with symptoms that have been present for 48-72 hours before starting treatment. Acute bronchitis is a sudden inflammation of the airways in the lungs.
  • Be a male or female patient of any ethnic background.
  • Be between the ages of 18 and 75, inclusive.
  • Be able to understand and willing to follow the study rules.
  • Have given written informed consent to participate in the study. This means you agree to join the study after being informed about it.
  • Be in good health, except for the existing bronchitis, as determined by the study doctor based on your medical history and physical examination.
  • Have a **CS score** of at least 50 mm on the 100 mm **VAS** at the first visit. The CS score is a measure of cough severity, and VAS stands for Visual Analog Scale, which is a tool to measure the intensity of symptoms.
  • Have a **BSS** of at least 10 points at the first visit. BSS stands for Bronchitis Severity Score, which measures how severe the bronchitis symptoms are.
  • Have a **VCD score** of at least 2 points at the first visit. VCD stands for Volume of Cough Data, which measures the amount of coughing.

Who cannot join the trial?

9 criteria

  • Patients with a history of **chronic bronchitis**. Chronic bronchitis is a long-term inflammation of the airways in the lungs.
  • Patients with **asthma**. Asthma is a condition where the airways become narrow and swell, making it hard to breathe.
  • Patients with **chronic obstructive pulmonary disease (COPD)**. COPD is a group of lung diseases that block airflow and make it difficult to breathe.
  • Patients who have had a **lung infection** in the past 4 weeks. A lung infection can be caused by bacteria, viruses, or fungi.
  • Patients with a known **allergy** to the study medication. An allergy is when the body's immune system reacts to a substance as if it were harmful.
  • Patients who are currently taking other medications that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial in the last 30 days.
  • Patients with any other medical condition that the study doctors think might make it unsafe for them to participate.
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Investigated drugs

  • Test

    is a herbal medicinal product being evaluated for its effectiveness in treating acute bronchitis. The trial aims to determine if this product can reduce the severity of bronchitis symptoms over a period of 7 days.

  • Reference 1

    is another herbal medicinal product used as a comparison to the Test product. The trial assesses whether the Test product is at least as effective as Reference 1 in alleviating symptoms of acute bronchitis.

  • Reference 2

    is the third herbal medicinal product included in the trial. It serves as an additional comparison to evaluate the effectiveness of the Test product in reducing bronchitis symptoms over the same 7-day period.

What is already known about the treatment

  • Herbal Medicinal Product 1

    This medication is administered orally in the form of tablets or syrup. It is currently being studied in clinical trials for its effectiveness in treating acute bronchitis. The main therapeutic indication is to alleviate symptoms associated with acute bronchitis, such as cough and mucus production. The mechanism of action involves modulating the immune response and reducing inflammation in the respiratory tract. It is classified as a herbal medicine, focusing on natural plant extracts to provide relief.

  • Herbal Medicinal Product 2

    This medication is also administered orally, available as tablets or syrup. It is under investigation in clinical trials to determine its safety and efficacy for acute bronchitis treatment. The primary therapeutic use is to reduce the severity of bronchitis symptoms, including cough and congestion. Its mechanism of action includes soothing the respiratory tract and enhancing mucus clearance. It belongs to the category of herbal medicines, utilizing plant-based ingredients for therapeutic effects.

  • Herbal Medicinal Product 3

    This medication is taken orally, offered in tablet or syrup form. It is part of ongoing clinical trials aimed at evaluating its role in managing acute bronchitis. The main therapeutic purpose is to ease symptoms like persistent cough and chest discomfort. The mechanism of action involves anti-inflammatory properties and support for respiratory health. It is classified as a herbal medicinal product, relying on natural compounds to aid in symptom relief.

Investigated diseases

Acute bronchitis – Acute bronchitis is an inflammation of the bronchial tubes, which are the airways that carry air to the lungs. It often develops from a cold or other respiratory infection and is characterized by a persistent cough that may produce mucus. The condition typically begins with a dry cough, which can later become productive, meaning it brings up mucus. Other symptoms may include fatigue, shortness of breath, slight fever, and chest discomfort. The inflammation usually lasts for a few days to a week, but the cough can linger for several weeks. It is a common condition that can affect people of all ages.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507370-41-00Protocol codeEA-20-01-032Estimated enrolment300 patientsSponsorEngelhard Arzneimittel GmbH & Co. KG

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