#1 Clinical Trials Search in Europe

Liquid Extract From Thyme Herb (Der 1:2-2,5), Extraction Solvents: Ammonia Solution 10 % (M/M), Glycerol 85%, Ethanol 90%, Water (1:20:70:109)

This article discusses a clinical trial investigating the use of a liquid extract from thyme herb, along with other herbal ingredients, in treating acute bronchitis. The study aims to compare the efficacy and safety of three herbal medicinal products, focusing on the thyme herb extract as one of the key components. This randomized, controlled, open-label, multi-center trial seeks to evaluate the effectiveness of these natural remedies in managing bronchitis symptoms and improving patient outcomes.

Table of Contents

What is Thyme Herb Extract?

Thyme herb extract is a natural medicine derived from the thyme plant. The specific product being studied is called “LIQUID EXTRACT FROM THYME HERB (DER 1:2-2,5), EXTRACTION SOLVENTS: AMMONIA SOLUTION 10 % (M/M), GLYCEROL 85%, ETHANOL 90%, WATER (1:20:70:109).” This long name describes how the extract is prepared, ensuring a standardized and consistent product. It’s also known by its simpler name, “thyme herb fluid extract.”[1]

Medical Use: Treating Acute Bronchitis

The primary use of this thyme herb extract is for the treatment of acute bronchitis. Acute bronchitis is a short-term inflammation of the airways (bronchi) in your lungs, usually caused by a viral infection. It typically causes coughing, which may be accompanied by mucus production, wheezing, and chest discomfort.[1]

Current Clinical Trial

A clinical trial is currently being conducted to evaluate the effectiveness and safety of this thyme herb extract compared to two other herbal products for treating acute bronchitis. The trial is described as a “Randomized, controlled, open-label, multi-center trial.”[1] Here’s what these terms mean:

  • Randomized: Participants are randomly assigned to different treatment groups.
  • Controlled: The thyme extract is being compared to other treatments (called “reference” products).
  • Open-label: Both the patients and the doctors know which treatment is being given.
  • Multi-center: The study is being conducted at multiple medical facilities.

How It Works

While the exact mechanism isn’t fully explained in the trial information, herbal extracts like thyme are often used for their potential anti-inflammatory, antispasmodic (reducing muscle spasms), and expectorant (helping to clear mucus) properties. These effects may help relieve the symptoms of acute bronchitis.[1]

Dosage and Administration

The thyme herb extract is administered orally as drops (also called “tropfen” in German). The maximum daily dose is 175 drops, and the maximum total dose over the treatment period is 1225 drops. The treatment period lasts for 7 days.[1]

Eligibility Criteria for the Clinical Trial

To participate in this clinical trial, patients must meet certain criteria. Some key inclusion criteria are:

  • Acute bronchitis symptoms present for 48-72 hours prior to treatment
  • Age between 18 and 75 years
  • A certain level of cough severity and overall bronchitis symptoms

Some key exclusion criteria (reasons why someone cannot participate) include:

  • Having chronic lung diseases or allergic bronchial asthma
  • Pregnancy or breastfeeding
  • Body temperature above 38.3°C
  • History of hypersensitivity to any of the ingredients

It’s important to note that these criteria are specific to the clinical trial and may not all apply to general use of the product once it’s approved.[1]

Potential Benefits

The main goal of the treatment is to reduce the severity of bronchitis symptoms. This is measured using the Bronchitis Severity Score (BSS), which takes into account various symptoms of bronchitis. The trial also looks at improvements in cough severity specifically.[1]

Precautions and Contraindications

Based on the trial’s exclusion criteria, this treatment may not be suitable for people with:

  • Chronic lung diseases or allergic bronchial asthma
  • A history of gastrointestinal bleeding or ulcers
  • Significant cardiovascular, liver, or kidney disease
  • Known allergies to any of the ingredients
  • Hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency

As with any medication, it’s crucial to consult with a healthcare provider before starting this or any new treatment.[1]

Aspect Details
Trial Type Randomized, controlled, open-label, multi-center
Main Ingredient Liquid Extract From Thyme Herb (DER 1:2-2,5)
Condition Studied Acute bronchitis
Primary Endpoint Change in Bronchitis Severity Score (BSS) after 7 days
Treatment Duration 7 days
Observation Period 14 days
Age Range 18-75 years
Key Measurements BSS, Cough Severity (CS), Visual Analogue Scale (VAS), Verbal Category Descriptive (VCD) score
Safety Evaluation Adverse Events monitoring, global tolerability assessment

FAQ

  • What is the main objective of this clinical trial? The main objective is to assess the non-inferiority of the test product (containing thyme herb extract) compared to two reference products in reducing the Bronchitis Severity Score (BSS) after 7 days of treatment in patients with acute bronchitis.
  • 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 such as a minimum cough severity score and Bronchitis Severity Score. Certain medical conditions and recent use of specific medications may exclude participation.
  • How long does the trial last? The trial has an observation period of 14 days, with consecutive treatment over the first 7 days. The investigational medicinal product (IMP) is administered orally according to the dosage scheme specified in the SmPC (Summary of Product Characteristics).
  • What is being measured in this trial? The primary measurement is the change in Bronchitis Severity Score (BSS) between the baseline visit and after 7 days of treatment. Secondary measurements include changes in cough severity, global efficacy assessments, and safety evaluations.
  • Are there any risks associated with participating in this trial? While the trial uses herbal medicinal products with existing marketing authorization, there may be potential risks. Participants with allergies, certain medical conditions, or those taking specific medications are excluded to minimize risks. The trial also monitors for adverse events and evaluates the tolerability of the treatments.

Ongoing Clinical Trials on Liquid Extract From Thyme Herb (Der 1:2-2,5), Extraction Solvents: Ammonia Solution 10 % (M/M), Glycerol 85%, Ethanol 90%, Water (1:20:70:109)

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

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Acute bronchitis: A sudden inflammation of the airways (bronchi) in the lungs, usually caused by a viral infection and characterized by coughing, mucus production, and sometimes wheezing or shortness of breath.
  • Bronchitis Severity Score (BSS): A clinical assessment tool used to measure the severity of bronchitis symptoms, including cough, sputum production, chest pain, difficulty breathing, and lung sounds.
  • Visual Analogue Scale (VAS): A measurement tool used to assess subjective characteristics or attitudes that cannot be directly measured, often represented as a line with two endpoints representing extreme values.
  • Verbal Category Descriptive (VCD) score: A scoring system used to categorize and describe the severity of symptoms using words or phrases, often used in clinical assessments.
  • Non-inferiority: A type of clinical trial design aimed at demonstrating that a new treatment is not worse than a standard treatment by more than a pre-specified margin.
  • Phytopharmaceutical: A medicinal product derived from plants or plant-based substances, often used in herbal medicine.
  • Investigational Medicinal Product (IMP): A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial.
  • Summary of Product Characteristics (SmPC): A legal document approved as part of the marketing authorization of each medicine, containing essential information for healthcare professionals on how to use the medicine safely and effectively.
  • Area Under the Curve (AUC): A statistical measure used to summarize the overall effect or exposure of a treatment over time, often used in pharmacology and clinical trials.

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/