In short
This article explores a clinical trial investigating the use of Dry Extract of Hederae Folium (5-7.5:1), Extraction Solvent: Ethanol 30% (M/M), commonly known as ivy leaf extract, in treating acute bronchitis. The study compares the efficacy and safety of this herbal medicinal product with two other treatments. We'll discuss the trial's objectives, eligibility criteria, and potential benefits for patients suffering from acute bronchitis.
At a glance
- Trial Type
- Randomized, controlled, open-label, multi-center
- Main Objective
- Assess non-inferiority of ivy leaf extract vs. two reference products for acute bronchitis treatment
- Primary Endpoint
- Change in Bronchitis Severity Score (BSS) after 7 days of treatment
- Treatment Duration
- 7 days of consecutive treatment, 14 days total observation
- Ivy Extract Product
- Prospan® Hustentropfen (cough drops)
- Dosage
- Maximum 72 drops daily, 504 drops total over 7 days
- Key Inclusion Criteria
- Age 18-75, acute bronchitis symptoms for 48-72 hours, specific symptom severity scores
- Key Exclusion Criteria
- Chronic lung diseases, recent use of certain medications, pregnancy, high fever
What is Ivy Leaf Extract?
Ivy leaf extract, scientifically known as dry extract of Hederae folium, is a natural remedy derived from the leaves of the ivy plant. The specific formulation discussed in this article is prepared using a 5-7.5:1 extraction process with 30% ethanol as the solvent. This extract is the active ingredient in a medication called Prospan® Hustentropfen, which is used to treat respiratory conditions, particularly acute bronchitis.
Medical Uses
The primary medical use of ivy leaf extract is in the treatment of acute bronchitis. Acute bronchitis is a temporary inflammation of the airways (bronchi) in the lungs, usually caused by a viral infection. It typically causes coughing, which may be accompanied by mucus production, chest discomfort, and other respiratory symptoms.
How It Works
Ivy leaf extract 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 cough and make breathing easier for people with acute bronchitis.
Dosage and Administration
Prospan® Hustentropfen, which contains ivy leaf extract, comes in the form of oral drops. The maximum daily dose is 72 drops, with a maximum total dose of 504 drops over a 7-day treatment period. However, it's crucial to follow the specific dosage instructions provided by your healthcare provider or as indicated on the product label.
Clinical Trial Information
A clinical trial is being conducted to compare the efficacy and safety of ivy leaf extract (referred to as the "Test" product) with two other herbal medicinal products for treating acute bronchitis. This trial aims to: Assess whether ivy leaf extract is as effective as the other products in reducing the severity of bronchitis symptoms Evaluate if ivy leaf extract might be superior to the other products Compare the safety and tolerability of all three treatments The main measure of effectiveness in this trial is the change in the Bronchitis Severity Score (BSS) after 7 days of treatment. The BSS is a tool used by doctors to assess the severity of bronchitis symptoms.
Eligibility Criteria
To participate in the clinical trial, patients must meet certain criteria. Some key inclusion criteria are: Acute bronchitis symptoms present for 48-72 hours Age between 18 and 75 years A certain level of cough severity and overall bronchitis symptoms Exclusion criteria include: Chronic lung diseases like asthma or chronic bronchitis Pregnancy or breastfeeding Recent use of certain medications that could interfere with the study results These criteria help ensure the safety of participants and the reliability of the study results.
Potential Benefits
Based on its use as an expectorant, ivy leaf extract may offer several potential benefits for people with acute bronchitis: Reduction in cough severity Easier expectoration (coughing up) of mucus Improvement in overall bronchitis symptoms Potentially faster recovery from acute bronchitis However, it's important to note that individual responses to the medication may vary, and these benefits are being further evaluated in the clinical trial.
Precautions and Contraindications
While ivy leaf extract is generally considered safe when used as directed, there are some precautions to keep in mind: It should not be used by people with known allergies to ivy or any of the product's ingredients Caution is advised for people with a history of gastrointestinal issues It may not be suitable for people with certain hereditary conditions affecting sugar metabolism The product contains a small amount of alcohol, which may be a concern for some individuals Always consult with a healthcare provider before starting any new medication, including herbal remedies like ivy leaf extract.