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Primrose Root Tincture (1:5), Extracting Solvent: Ethanol 50 % (V/V)

This article discusses the use of Primrose Root Tincture (1:5), with Ethanol 50% (V/V) as the extracting solvent, in clinical trials for the treatment of acute bronchitis. The tincture is being studied alongside other herbal medicinal products to assess its efficacy and safety in managing bronchitis symptoms. The trials aim to compare this herbal remedy with other reference products and evaluate its potential benefits for patients suffering from acute bronchitis.

Table of Contents

What is Primrose Root Tincture?

Primrose Root Tincture is a herbal medicine extracted from the roots of the primrose plant. It is specifically prepared as a tincture, which means the active ingredients are extracted using a solution of alcohol and water. In this case, the tincture is made using a 1:5 ratio of primrose root to extracting solvent, with the solvent being 50% ethanol (alcohol) by volume[1].

Medical Uses

The primary medical use of Primrose Root Tincture, as indicated by the clinical trial data, is for the treatment of acute bronchitis. Acute bronchitis is a condition characterized by inflammation of the bronchial tubes, which are the airways that carry air to and from your lungs. This inflammation often leads to coughing, mucus production, and other respiratory symptoms[1].

Clinical Trial Information

A clinical trial is being conducted to evaluate the effectiveness and safety of Primrose Root Tincture, along with other herbal products, in treating acute bronchitis. Here are some key points about the trial:

  • The trial is randomized, controlled, and open-label, meaning participants are randomly assigned to different treatment groups, and both the researchers and participants know which treatment is being given.
  • It’s a multi-center trial, which means it’s being conducted at multiple medical facilities.
  • The main objective is to assess whether the test product (which includes Primrose Root Tincture) is as effective as two reference products in reducing the severity of bronchitis symptoms[1].

The effectiveness of the treatment is primarily measured using the Bronchitis Severity Score (BSS). This score takes into account various symptoms of bronchitis and helps researchers quantify how well the treatment is working[1].

Dosage and Administration

According to the clinical trial information:

  • The medication is administered orally (by mouth) in the form of drops.
  • The maximum daily dose is 175 drops.
  • The maximum total dose over the treatment period is 1225 drops.
  • The treatment period lasts for 7 days[1].

It’s important to note that this dosage is specific to the clinical trial and may not reflect the recommended dosage for general use. Always follow the instructions provided by your healthcare provider or the product label.

Eligibility Criteria

The clinical trial has specific criteria for who can participate. Some key inclusion criteria are:

  • Adults aged 18-75 years
  • Diagnosed with acute bronchitis with symptoms present for 48-72 hours prior to treatment
  • 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[1]

There are also several exclusion criteria, such as having allergic bronchial asthma, chronic bronchitis, or other chronic lung diseases.

Safety and Precautions

While herbal remedies like Primrose Root Tincture are often considered natural and safe, it’s important to be aware of potential risks and precautions:

  • The tincture contains alcohol, so it may not be suitable for everyone, particularly those with a history of alcohol abuse or liver problems.
  • People with a history of drug hypersensitivity, asthma, severe allergies, or current hay fever are excluded from the trial, suggesting these conditions may increase the risk of adverse reactions.
  • The trial excludes pregnant or breastfeeding women, indicating that the safety of the tincture in these populations is not established[1].

As with any medication, it’s crucial to consult with a healthcare professional before starting treatment with Primrose Root Tincture, especially if you have any pre-existing health conditions or are taking other medications.

Aspect Details
Study Type Randomized, controlled, open-label, multi-center trial
Main Objective Assess non-inferiority of test product vs. two reference products for acute bronchitis treatment
Primary Endpoint Change in Bronchitis Severity Score (BSS) after 7 days of treatment
Secondary Endpoints Changes in BSS over time, cough severity (CS) using VAS and VCD, global efficacy, safety, and tolerability
Inclusion Criteria Adults 18-75 years, acute bronchitis symptoms for 48-72 hours, minimum BSS and CS scores
Exclusion Criteria Chronic lung diseases, recent use of certain medications, pregnancy, high body temperature
Treatment Duration 7 days of consecutive treatment, 14 days total observation
Product Tested Bronchicum Tropfen containing Primrose Root Tincture (1:5), Extracting Solvent: Ethanol 50% (V/V)

FAQ

  • What is the main purpose of the clinical trial using Primrose Root Tincture? The main purpose is to assess the non-inferiority of the test product (which includes Primrose Root Tincture) compared to two reference products in treating acute bronchitis. The trial 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 such as minimum cough severity and Bronchitis Severity Scores. They must also be in generally good health apart from the bronchitis.
  • How is the effectiveness of the treatment measured? The primary measure is the change in Bronchitis Severity Score (BSS) between the start of treatment and after 7 days. Secondary measures include cough severity assessed using a Visual Analogue Scale (VAS) and Verbal Category Descriptive (VCD) score.
  • Are there any specific exclusion criteria for the trial? Yes, people with conditions such as allergic bronchial asthma, chronic bronchitis, pregnancy, high body temperature (>38.3°C), or those taking certain medications are excluded. Additionally, those with a history of drug hypersensitivity or severe allergies cannot participate.
  • How long does the trial last for each participant? The trial includes one observation period over 14 days, with consecutive treatment during the first 7 days. The investigational medicinal product is administered orally according to the dosage scheme specified in the SmPC (Summary of Product Characteristics).

Ongoing Clinical Trials on Primrose Root Tincture (1:5), Extracting Solvent: Ethanol 50 % (V/V)

  • 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 temporary 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.
  • 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 assess the severity of their condition.
  • 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.
  • Phytopharmaceutical: A medicinal product derived from plants or plant materials, 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.

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/