In short
This article discusses a clinical trial investigating the use of Thyme Herb Fluid Extract (1:2-2,5) in combination with other herbal extracts for the treatment of acute bronchitis. The study aims to compare the efficacy and safety of three herbal medicinal products in managing this common respiratory condition. The trial focuses on assessing changes in bronchitis symptoms and cough severity over a treatment period of 7 days.
At a glance
- Study Type
- Randomized, controlled, open-label, multi-center trial
- Condition
- Acute bronchitis
- Main Intervention
- Thyme Herb Fluid Extract (1:2-2,5) in combination with other herbal extracts
- Comparators
- Two reference herbal medicinal products
- Primary Outcome
- Change in Bronchitis Severity Score (BSS) after 7 days of treatment
- Secondary Outcomes
- Changes in cough severity, global efficacy assessments, safety evaluations
- Treatment Duration
- 7 days
- Total Study Duration
- 14 days
- Key Inclusion Criteria
- Age 18-75, acute bronchitis symptoms for 48-72 hours, specific BSS and cough severity scores
- Key Exclusion Criteria
- Chronic lung diseases, allergies, pregnancy, recent use of certain medications
Overview of Thyme Herb Fluid Extract
Thyme Herb Fluid Extract is a herbal medicinal product being studied for the treatment of acute bronchitis. This extract is also known as THYME HERB FLUID EXTRACT (1:2-2,5), EXTRACTING AGENT: AMMONIA 10 % : GYCEROL 85 % : ETHANOL 90 % (V/V) : WATER (1 : 20 : 70 : 109). It is part of a combination product that includes other herbal extracts such as primrose root tincture or ivy leaf extract, depending on the specific formulation.
Medical Condition: Acute Bronchitis
The primary medical condition targeted by this herbal extract is acute bronchitis. Acute bronchitis is an inflammation of the bronchial tubes, which are the airways that carry air to and from the lungs. This condition is typically characterized by coughing, which may be accompanied by mucus production, and other symptoms such as shortness of breath and chest discomfort.
Clinical Trial Information
A randomized, controlled, open-label, multi-center trial is being conducted to compare the efficacy and safety of three herbal medicinal products, including the Thyme Herb Fluid Extract, in the treatment of acute bronchitis. This is a Phase IV clinical trial, meaning that the products being tested already have marketing authorization and are being used in line with their approved specifications.
Efficacy and Safety
The main objective of the clinical trial is to assess the non-inferiority of the test product (which includes Thyme Herb Fluid Extract) compared to two reference products. This assessment is based on the change in the Bronchitis Severity Score (BSS) in patients with acute bronchitis after 7 days of treatment. The BSS is a clinical measure used to evaluate the severity of bronchitis symptoms.
Secondary objectives include: Evaluating the superiority of the test product compared to the reference products Assessing changes in cough severity using a Visual Analogue Scale (VAS) and Verbal Category Descriptive (VCD) score Evaluating the global efficacy and safety of all treatments
Administration and Dosage
The Thyme Herb Fluid Extract is administered orally as part of a liquid formulation. In the clinical trial, the treatment period is 7 days, with the investigational medicinal product (IMP) being administered according to the dosage scheme specified in the Summary of Product Characteristics (SmPC). The maximum daily dose is 175 drops, with a maximum total dose of 1225 drops over the 7-day treatment period.
Eligibility Criteria
To be eligible for the clinical trial, patients must meet certain criteria, including: Having acute bronchitis with symptoms present for 48-72 hours prior to treatment Being between 18 and 75 years old Having a cough severity score of at least 50 mm on a 100 mm Visual Analogue Scale Having a Bronchitis Severity Score of at least 10 points
Precautions and Contraindications
The clinical trial excludes patients with certain conditions or characteristics, including: Allergic bronchial asthma, chronic bronchitis, or other chronic lung diseases Pregnancy or lactation Body temperature above 38.3°C History of hypersensitivity to any of the constituents of the investigational medicinal products History of chronic gastritis or peptic ulcer Known hereditary fructose-intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency These exclusion criteria suggest potential precautions and contraindications for the use of Thyme Herb Fluid Extract in certain patient populations.