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Thyme Herb Fluid Extract (1:2-2,5), Extracting Agent: Ammonia 10 % : Gycerol 85 % : Ethanol 90 % (V/V) : Water (1 : 20 : 70 : 109)

This article discusses a clinical trial investigating the use of Thyme Herb Fluid Extract (1:2-2,5) in combination with other herbal extracts for the treatment of acute bronchitis. The study aims to compare the efficacy and safety of three herbal medicinal products in managing this common respiratory condition. The trial focuses on assessing changes in bronchitis symptoms and cough severity over a treatment period of 7 days.

Table of Contents

Overview of Thyme Herb Fluid Extract

Thyme Herb Fluid Extract is a herbal medicinal product being studied for the treatment of acute bronchitis. This extract is also known as THYME HERB FLUID EXTRACT (1:2-2,5), EXTRACTING AGENT: AMMONIA 10 % : GYCEROL 85 % : ETHANOL 90 % (V/V) : WATER (1 : 20 : 70 : 109). It is part of a combination product that includes other herbal extracts such as primrose root tincture or ivy leaf extract, depending on the specific formulation[1].

Medical Condition: Acute Bronchitis

The primary medical condition targeted by this herbal extract is acute bronchitis. Acute bronchitis is an inflammation of the bronchial tubes, which are the airways that carry air to and from the lungs. This condition is typically characterized by coughing, which may be accompanied by mucus production, and other symptoms such as shortness of breath and chest discomfort[1].

Clinical Trial Information

A randomized, controlled, open-label, multi-center trial is being conducted to compare the efficacy and safety of three herbal medicinal products, including the Thyme Herb Fluid Extract, in the treatment of acute bronchitis. This is a Phase IV clinical trial, meaning that the products being tested already have marketing authorization and are being used in line with their approved specifications[1].

Efficacy and Safety

The main objective of the clinical trial is to assess the non-inferiority of the test product (which includes Thyme Herb Fluid Extract) compared to two reference products. This assessment is based on the change in the Bronchitis Severity Score (BSS) in patients with acute bronchitis after 7 days of treatment. The BSS is a clinical measure used to evaluate the severity of bronchitis symptoms[1].

Secondary objectives include:

  • Evaluating the superiority of the test product compared to the reference products
  • Assessing changes in cough severity using a Visual Analogue Scale (VAS) and Verbal Category Descriptive (VCD) score
  • Evaluating the global efficacy and safety of all treatments

Administration and Dosage

The Thyme Herb Fluid Extract is administered orally as part of a liquid formulation. In the clinical trial, the treatment period is 7 days, with the investigational medicinal product (IMP) being administered according to the dosage scheme specified in the Summary of Product Characteristics (SmPC). The maximum daily dose is 175 drops, with a maximum total dose of 1225 drops over the 7-day treatment period[1].

Eligibility Criteria

To be eligible for the clinical trial, patients must meet certain criteria, including:

  • Having acute bronchitis with symptoms present for 48-72 hours prior to treatment
  • Being between 18 and 75 years old
  • Having a cough severity score of at least 50 mm on a 100 mm Visual Analogue Scale
  • Having a Bronchitis Severity Score of at least 10 points

Precautions and Contraindications

The clinical trial excludes patients with certain conditions or characteristics, including:

  • Allergic bronchial asthma, chronic bronchitis, or other chronic lung diseases
  • Pregnancy or lactation
  • Body temperature above 38.3°C
  • History of hypersensitivity to any of the constituents of the investigational medicinal products
  • History of chronic gastritis or peptic ulcer
  • Known hereditary fructose-intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency
These exclusion criteria suggest potential precautions and contraindications for the use of Thyme Herb Fluid Extract in certain patient populations[1].

Aspect Details
Study Type Randomized, controlled, open-label, multi-center trial
Condition Acute bronchitis
Main Intervention Thyme Herb Fluid Extract (1:2-2,5) in combination with other herbal extracts
Comparators Two reference herbal medicinal products
Primary Outcome Change in Bronchitis Severity Score (BSS) after 7 days of treatment
Secondary Outcomes Changes in cough severity, global efficacy assessments, safety evaluations
Treatment Duration 7 days
Total Study Duration 14 days
Key Inclusion Criteria Age 18-75, acute bronchitis symptoms for 48-72 hours, specific BSS and cough severity scores
Key Exclusion Criteria Chronic lung diseases, allergies, pregnancy, recent use of certain medications

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to assess the non-inferiority of a test product containing Thyme Herb Fluid Extract compared to two reference products in treating acute bronchitis. The study measures the change in Bronchitis Severity Score (BSS) after 7 days of treatment.
  • 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 be in generally good health aside from the bronchitis and willing to follow study rules.
  • What are some reasons why someone might not be able to participate in this trial? People with allergic bronchial asthma, chronic bronchitis, other chronic lung diseases, or a history of drug hypersensitivity cannot participate. Additionally, pregnant or breastfeeding women, those with a body temperature above 38.3°C, or individuals taking certain medications in the past 7 days are excluded.
  • How long does the trial last, and what does it involve? The trial lasts for 14 days, with treatment given for the first 7 days. Participants will take the assigned herbal product orally according to the dosage instructions. The study involves multiple visits to assess bronchitis symptoms, cough severity, and overall efficacy of the treatment.
  • What are the main outcomes being measured in this trial? The primary outcome is the change in Bronchitis Severity Score (BSS) between the start of treatment and after 7 days. Secondary outcomes include changes in cough severity measured by visual and verbal scales, global efficacy assessments by both patients and investigators, and safety evaluations of the treatments.

Ongoing Clinical Trials on Thyme Herb Fluid Extract (1:2-2,5), Extracting Agent: Ammonia 10 % : Gycerol 85 % : Ethanol 90 % (V/V) : 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 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 assessment tool used to measure the severity of bronchitis symptoms, including cough, sputum production, and chest discomfort.
  • Non-inferiority: A type of clinical trial design that aims to show that a new treatment is not worse than an existing treatment by more than a pre-specified margin.
  • 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 that uses words or phrases to describe the severity or intensity of a symptom, such as cough.
  • Area under the curve (AUC): A statistical measure used to analyze the overall effect of a treatment over time, considering multiple data points throughout the study period.
  • Phytopharmaceutical: A medicinal product derived from plants or plant-based substances, often used in herbal medicine.
  • Expectorant: A type of medication that helps to clear mucus from the airways, making it easier to cough up and expel.
  • Fluid extract: A concentrated liquid preparation of a plant or herb, typically made by extracting the plant material with a solvent such as alcohol or water.

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/