#1 Clinical Trials Search in Europe

Fluid Extract From Ivy Leaves (1:1), Extracting Agent: Ethanol 70% (V/V)

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.

Table of Contents

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[1]. 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[1]. 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[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 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[1]. 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[1]. 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[1]. 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[1].

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[1].

Aspect Details
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

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to assess whether the combination of ivy leaf extract and thyme herb extract is as effective as two other herbal treatments in reducing the severity of acute bronchitis symptoms after 7 days of treatment.
  • Who can participate in this clinical trial? Adults aged 18-75 with acute bronchitis symptoms present for 48-72 hours, a certain level of cough severity, and meeting other specific health criteria can participate. However, people with chronic lung diseases, allergies, or taking certain medications are excluded.
  • How is the effectiveness of the treatment measured? The main measure is the change in the Bronchitis Severity Score (BSS) after 7 days of treatment. Other measures include cough severity using a Visual Analogue Scale (VAS) and a Verbal Category Descriptive (VCD) score.
  • What is the duration of the treatment and observation in this trial? The trial involves a 14-day observation period, with consecutive treatment given over the first 7 days. The medication is taken orally according to the dosage instructions.
  • Are there any safety concerns for participants? The trial monitors for adverse events and evaluates the overall tolerability of the treatments. Participants with certain health conditions or taking specific medications are excluded to ensure safety.

Ongoing Clinical Trials on Fluid Extract From Ivy Leaves (1:1), Extracting Agent: Ethanol 70% (V/V)

  • 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 short-term inflammation of the airways (bronchi) in the lungs, usually caused by a viral infection and characterized by coughing and other respiratory symptoms.
  • Bronchitis Severity Score (BSS): A clinical measure used to assess the severity of bronchitis symptoms, including cough, mucus production, chest pain, and difficulty breathing.
  • Visual Analogue Scale (VAS): A measurement tool used to assess subjective characteristics or attitudes that cannot be directly measured, often used for pain or symptom severity.
  • Verbal Category Descriptive (VCD) score: A scoring system where patients describe their symptoms using specific verbal categories, helping to quantify subjective experiences.
  • Phytopharmaceutical: A medicinal product derived from plants or plant extracts, used for therapeutic purposes.
  • Non-inferiority: A type of clinical trial design that aims 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 measure used to analyze the overall effect of a treatment over time, considering multiple data points.

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/