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Primula Veris, Flos Rec., Ethanol. Digestio 1:3,1 Cum 1 % Hyoscyamus Ø

This article discusses a clinical trial investigating the use of Cardiodoron®, a medication containing Primula Veris and other herbal extracts, for treating functional cardiovascular disorders (FCD). The study aims to evaluate the efficacy and safety of this anthroposophic medicinal product compared to a placebo in patients with FCD, including those with sleeping disorders.

Table of Contents

What is Cardiodoron®?

Cardiodoron® Dilution is an anthroposophic medicinal product used to treat certain heart and circulatory system disorders[1]. Anthroposophic medicine is a form of alternative medicine that combines conventional medical treatments with therapies based on spiritual science. This medication is specifically designed as oral drops, which means it is taken by mouth[1].

What Medical Conditions Does Cardiodoron® Treat?

Cardiodoron® is primarily used to treat functional cardiovascular disorders (FCD)[1]. FCDs are conditions where patients experience symptoms related to the heart and blood vessels, but without clear structural abnormalities. These disorders can include:

  • Cardiovascular somatic symptom disorder: A condition where a person experiences physical symptoms related to the heart or blood vessels that cause significant distress or disruption in daily life, even when no medical cause is found[1].
  • FCDs with or without sleeping disorders: Some patients may also experience sleep problems along with their cardiovascular symptoms[1].

Active Ingredients

Cardiodoron® Dilution contains two main active ingredients[1]:

  1. ONOPORDUM ACANTHIUM, FLOS REC., ETHANOL. DIGESTIO 1:3,1 CUM 1 % HYOSCYAMUS Ø: This is an extract from the flower of Onopordum acanthium (cotton thistle) combined with a small amount of Hyoscyamus (henbane)[1].
  2. PRIMULA VERIS, FLOS REC., ETHANOL. DIGESTIO 1:3,1 CUM 1 % HYOSCYAMUS Ø: This is an extract from the flower of Primula veris (cowslip) also combined with a small amount of Hyoscyamus[1].
These ingredients are prepared using a special process called “ethanol digestio,” which is a method of extracting active compounds from plants using alcohol[1].

How to Use Cardiodoron®

Cardiodoron® is administered as oral drops. The maximum daily dose is 60 drops, and the maximum total dose over the treatment period is 5,340 drops[1]. However, always follow your doctor’s instructions for the correct dosage, as it may vary depending on your specific condition.

Current Clinical Trial

A clinical trial is currently being conducted to further investigate the effects of Cardiodoron® on patients with functional cardiovascular disorders[1]. This trial is:

  • A phase IV trial, which means it’s studying an already approved medication to gather more information about its effects and optimal use[1].
  • Double-blind and placebo-controlled, meaning neither the patients nor the researchers know who is receiving the real medication or a placebo (an inactive substance) during the study[1].
  • Conducted at a single center in Germany[1].

Who Can Participate in the Trial?

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

  • Patients of all sexes, aged 18 to 80 years[1].
  • Presence of functional cardiovascular disorders with or without sleeping disorders[1].
  • Medium FCD severity (Visual Analog Scale score ≥ 4 out of 10)[1].
Some exclusion criteria include:
  • Known organic cause of complaints[1].
  • Pregnant or lactating women[1].
  • Patients with certain existing cardiac diseases or other severe health conditions[1].

Objectives of the Clinical Trial

The main objectives of this clinical trial are to:

  • Identify suitable ways to measure the effectiveness of Cardiodoron® compared to a placebo[1].
  • Determine how much of an effect Cardiodoron® has compared to a placebo[1].
  • Evaluate the safety of Cardiodoron®[1].

Safety and Efficacy Measures

The trial will measure several aspects to determine how well Cardiodoron® works and how safe it is:

  • Changes in FCD severity and symptoms[1].
  • Improvements in quality of life[1].
  • Effects on blood pressure[1].
  • Improvements in sleep quality[1].
  • Patient and investigator satisfaction with the treatment[1].
  • Any side effects or adverse events that occur during the trial[1].

It’s important to note that while Cardiodoron® is already in use, this clinical trial aims to provide more detailed information about its effects and safety. If you’re considering using this medication, always consult with your healthcare provider to determine if it’s appropriate for your specific condition.

Aspect Details
Study Type Phase IV, randomized, double-blind, placebo-controlled
Medication Cardiodoron® (containing Primula Veris extract)
Condition Functional Cardiovascular Disorders (FCD)
Primary Objectives Identify suitable endpoints, determine effect size, evaluate safety
Key Measurements FCD severity (VAS), symptom scores, quality of life, blood pressure
Participant Age 18-80 years
Treatment Duration Up to 89 days
Safety Monitoring Adverse events, lab parameters, treatment satisfaction

FAQ

  • What is Cardiodoron® and what is it used for? Cardiodoron® is an anthroposophic medicinal product containing herbal extracts, including Primula Veris. It is being studied for the treatment of functional cardiovascular disorders (FCD), which are heart-related symptoms without a clear organic cause.
  • Who can participate in this clinical trial? The trial is open to adults aged 18 to 80 with functional cardiovascular disorders of medium severity. Participants must not have any known organic cause for their symptoms and must meet other specific eligibility criteria.
  • What are the main objectives of this study? The main objectives are to identify suitable endpoints to show the superiority of Cardiodoron® over placebo, determine its effect size, and evaluate its safety in treating functional cardiovascular disorders.
  • How is the effectiveness of Cardiodoron® measured in this trial? The effectiveness is measured through various methods, including changes in FCD severity on a visual analog scale (VAS), symptom scores, quality of life assessments, and blood pressure measurements.
  • What safety measures are in place for this clinical trial? The trial monitors for adverse events, changes in laboratory parameters, and reasons for discontinuation. It also assesses patient and investigator satisfaction with the treatment's tolerability and efficacy.

Ongoing Clinical Trials on Primula Veris, Flos Rec., Ethanol. Digestio 1:3,1 Cum 1 % Hyoscyamus Ø

  • Study on the Effects of Cardiodoron Dilution for Patients with Functional Cardiovascular Disorders

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Functional Cardiovascular Disorders (FCD): Heart-related symptoms without a clear organic cause, often associated with discomfort but not linked to structural heart problems.
  • Anthroposophic medicinal product: A type of complementary medicine based on anthroposophy, integrating conventional medicine with a holistic approach to healing.
  • Placebo: An inactive substance or treatment used in clinical trials to compare the effects of a real medication.
  • Visual Analog Scale (VAS): A measurement tool used to assess subjective characteristics or attitudes that cannot be directly measured.
  • Quality of Life (QoL): A measure of an individual's overall well-being, including physical, mental, and social aspects of life.
  • Adverse Event: Any unfavorable and unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.
  • Efficacy: The ability of a treatment to produce the desired beneficial effect under ideal circumstances.
  • Phase IV Clinical Trial: A study conducted after a drug has been approved for use, to gather additional information about its safety, efficacy, or optimal use.
  • Randomized Controlled Trial (RCT): A type of scientific experiment where participants are randomly assigned to different treatment groups to compare outcomes.
  • Double-blind: A study design where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving the placebo.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-cardiodoron-dilution-for-patients-with-functional-cardiovascular-disorders/