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Dry Extract Of Hederae Folium (5-7.5:1), Extraction Solvent: Ethanol 30% (M/M)

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.

Table of Contents

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[1]. 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[1]. 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[1]. 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[1]. 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[1]. This trial aims to:

  1. Assess whether ivy leaf extract is as effective as the other products in reducing the severity of bronchitis symptoms
  2. Evaluate if ivy leaf extract might be superior to the other products
  3. 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[1]. 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[1]:

  • 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[1]:

  • 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.

Aspect Details
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

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this trial is to assess whether the ivy leaf extract (Test product) is as effective as two other reference products in reducing the severity of acute bronchitis symptoms after 7 days of treatment. This is measured using the Bronchitis Severity Score (BSS).
  • Who can participate in this clinical trial? Participants must be between 18 and 75 years old, have acute bronchitis symptoms present for 48-72 hours, and meet specific criteria for cough severity and bronchitis severity scores. They must also be in generally good health apart from the bronchitis.
  • How is the ivy leaf extract administered in this trial? The ivy leaf extract is administered orally as Prospan® Hustentropfen (cough drops). The maximum daily dose is 72 drops, with a total maximum dose of 504 drops over the 7-day treatment period.
  • What are some of the exclusion criteria for this trial? People with allergic bronchial asthma, chronic bronchitis, other chronic lung diseases, pregnancy, high fever (>38.3°C), or history of drug hypersensitivity cannot participate. Also, those who have taken certain medications like corticoids, expectorants, or antibiotics within the last 7 days are excluded.
  • How long does the trial last for each participant? The trial consists of one observation period lasting 14 days, with consecutive treatment over the first 7 days. Participants will be monitored and assessed throughout this period to evaluate the effectiveness and safety of the treatment.

Ongoing Clinical Trials on Dry Extract Of Hederae Folium (5-7.5:1), Extraction Solvent: Ethanol 30% (M/M)

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

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Acute Bronchitis: A temporary inflammation of the airways (bronchi) in the lungs, usually caused by a viral infection. It typically causes coughing and may be accompanied by other symptoms like mucus production and mild fever.
  • Bronchitis Severity Score (BSS): A clinical assessment tool used to measure the severity of bronchitis symptoms. It typically includes factors such as cough, sputum production, chest pain, and difficulty breathing.
  • Dry Extract of Hederae Folium: An extract derived from ivy leaves, commonly used in herbal medicines for respiratory conditions. In this trial, it's used in a specific concentration (5-7.5:1) with ethanol 30% as the extraction solvent.
  • Visual Analogue Scale (VAS): A measurement tool used to assess subjective characteristics or attitudes that cannot be directly measured. In this study, it's used to evaluate cough severity.
  • Verbal Category Descriptive (VCD) score: A scoring system where patients describe their symptoms using predefined verbal categories. In this trial, it's used as another method to assess cough severity.
  • Non-inferiority: A type of clinical trial design aimed to demonstrate that a new treatment is not worse than a standard treatment by more than a pre-specified margin.
  • Area Under the Curve (AUC): A statistical method used to analyze data over time. In this study, it's used to evaluate changes in symptom scores throughout the trial period.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-thyme-herb-extract-primrose-root-tincture-and-ivy-leaf-extract-for-patients-with-acute-bronchitis/