In short
This article discusses a clinical trial investigating the effectiveness of a herbal medicinal product containing Fluid Extract from Ivy Leaves (1:1), along with Thyme Herb Extract, for treating acute bronchitis. The study aims to compare this combination with other herbal treatments, focusing on symptom relief and safety in adult patients.
At a glance
- Study Type
- Randomized, controlled, open-label, multi-center trial
- Main Treatment
- Fluid Extract from Ivy Leaves (1:1) + Thyme Herb Extract
- Condition
- Acute Bronchitis
- Primary Outcome
- Change in Bronchitis Severity Score (BSS) after 7 days
- Secondary Outcomes
- Cough severity, global efficacy, safety, and tolerability
- Participant Age
- 18-75 years
- Treatment Duration
- 7 days
- Observation Period
- 14 days
- Maximum Daily Dose
- 7.8 ml
- Administration Route
- Oral use
What is Fluid Extract from Ivy Leaves?
Fluid Extract from Ivy Leaves (1:1), with an extracting agent of 70% ethanol (v/v), is a herbal medicine derived from ivy plants. It is one of the active ingredients in a product called Bronchipret® Tropfen, which is an oral liquid medication. This extract is classified as a structurally diverse substance of herbal origin, meaning it contains various natural compounds from the ivy plant.
Medical Conditions Treated
The primary medical condition that Fluid Extract from Ivy Leaves is used to treat is acute bronchitis. Acute bronchitis is an inflammation of the bronchial tubes, which are the airways that carry air to and from your lungs. This condition typically causes coughing, which may be accompanied by mucus production, and can last for several weeks.
How It Works
Fluid Extract from Ivy Leaves is classified as an expectorant. Expectorants are medications that help loosen and remove mucus from the airways. They work by: Increasing the water content of mucus, making it thinner and easier to cough up Stimulating the cough reflex, helping to clear the airways Potentially reducing inflammation in the bronchial tubes These actions can help relieve symptoms of acute bronchitis, such as coughing and chest congestion.
Administration and Dosage
Bronchipret® Tropfen, which contains Fluid Extract from Ivy Leaves, is administered orally as a liquid. The maximum daily dose is 7.8 ml, and the maximum total dose over a treatment period is 54.6 ml. The treatment typically lasts for 7 days. However, always follow your doctor's instructions or the product label for the correct dosage.
Current Clinical Trial
A clinical trial is currently being conducted to evaluate the effectiveness of Bronchipret® Tropfen (which contains Fluid Extract from Ivy Leaves) compared to other herbal medicinal products for treating acute bronchitis. The trial aims to: Assess the change in Bronchitis Severity Score (BSS) after 7 days of treatment Evaluate differences in cough severity using a Visual Analogue Scale (VAS) and Verbal Category Descriptive (VCD) score Assess the global efficacy and safety of the treatment This trial will provide valuable information about how well Fluid Extract from Ivy Leaves works compared to other treatments for acute bronchitis.
Eligibility Criteria
The clinical trial has specific eligibility criteria. Some key inclusion criteria are: Acute bronchitis with symptoms present for 48-72 hours prior to treatment Age between 18 and 75 years A cough severity score of at least 50 mm on a 100 mm Visual Analogue Scale A Bronchitis Severity Score of at least 10 points Some exclusion criteria include: Allergic bronchial asthma, chronic bronchitis, or other chronic lung diseases Pregnancy or lactation Body temperature above 38.3°C History of drug hypersensitivity or severe allergies These criteria help ensure the safety of participants and the reliability of the study results.
Safety and Precautions
While Fluid Extract from Ivy Leaves is generally considered safe when used as directed, there are some precautions to keep in mind: The product contains ethanol (alcohol), so it may not be suitable for people with a history of alcohol abuse or liver disease It should not be used by people with known hypersensitivity to any of the ingredients If you have a persistent cough or other severe symptoms, consult your doctor before using this product As with any medication, inform your healthcare provider about all other medicines and supplements you're taking to avoid potential interactions Always read the product label carefully and follow the recommended dosage instructions.