In short
This article discusses a clinical trial investigating the use of Cardiodoron® Dilution, containing Onopordum Acanthium and Primula Veris extracts, for patients with functional cardiovascular disorders (FCD). The study aims to evaluate the efficacy and safety of this anthroposophic medicinal product compared to a placebo in managing FCD symptoms and improving quality of life.
At a glance
- Study Type
- Phase IV, randomized, double-blind, placebo-controlled
- Medication
- Cardiodoron® Dilution (Onopordum Acanthium and Primula Veris extracts)
- Condition
- Functional Cardiovascular Disorders (FCD)
- Main Objectives
- Identify suitable endpoints, determine effect size, evaluate safety
- Key Inclusion Criteria
- Adults 18-80 years, FCD with/without sleep disorders, medium FCD severity
- Primary Endpoints
- Changes in FCD severity, symptom scores, quality of life, blood pressure, sleep quality
- Safety Assessments
- Adverse events, laboratory parameters, treatment discontinuation due to side effects
- Treatment Duration
- Up to 89 days
- Dosage Form
- Oral drops solution
What is Cardiodoron® Dilution?
Cardiodoron® Dilution is an anthroposophic medicinal product used to treat certain heart and circulatory system disorders. It is manufactured by WELEDA AG and is currently being studied in a clinical trial to evaluate its effectiveness and safety. Anthroposophic medicine is a form of complementary medicine that combines conventional medical treatments with natural remedies and holistic approaches.
Medical Conditions Treated
Cardiodoron® Dilution is primarily used to treat functional cardiovascular disorders (FCD). These are conditions where patients experience symptoms related to the heart and blood vessels, but without a clear organic cause. In medical terms, this is sometimes referred to as cardiovascular somatic symptom disorder. Symptoms may include: Heart palpitations (feeling your heart racing or pounding) Chest discomfort Shortness of breath Dizziness Fatigue The medication may also be beneficial for patients who have FCDs with associated sleeping disorders.
Active Ingredients
Cardiodoron® Dilution contains two main active ingredients: ONOPORDUM ACANTHIUM, FLOS REC., ETHANOL. DIGESTIO 1:3,1 CUM 1 % HYOSCYAMUS Ø: This is an ethanolic (alcoholic) extract of Onopordum acanthium (cotton thistle) flowers with 1% Hyoscyamus (henbane) tincture. PRIMULA VERIS, FLOS REC., ETHANOL. DIGESTIO 1:3,1 CUM 1 % HYOSCYAMUS Ø: This is an ethanolic extract of Primula veris (cowslip) flowers with 1% Hyoscyamus tincture. These plant-based ingredients are prepared using specific anthroposophic methods to create the final medicinal product.
How It Works
The exact mechanism of action for Cardiodoron® Dilution is not fully understood. However, anthroposophic medicine suggests that the combination of these plant extracts may help regulate heart rhythm, improve circulation, and balance the autonomic nervous system, which controls involuntary bodily functions like heart rate and blood pressure.
Dosage and Administration
Cardiodoron® Dilution is administered as oral drops. The maximum daily dose in the current clinical trial is 60 drops per day. Over the course of the study (89 days), the maximum total dose a patient might receive is 5,340 drops. However, it's important to note that the exact dosage for individual patients may vary and should be determined by a healthcare professional.
Current Clinical Trial
A clinical trial is currently underway to investigate the efficacy and safety of Cardiodoron® Dilution for patients with functional cardiovascular disorders. This is a Phase IV study, which means the medication is already approved for use, but researchers are gathering more information about its effects and optimal use.
The trial is designed as a: Parallel-group Low-intervention Randomized Double-blind Placebo-controlled Single-center National Two-arm study This means that participants will be randomly assigned to receive either Cardiodoron® Dilution or a placebo (a substance with no active ingredients), and neither the patients nor the researchers will know who is receiving which treatment until the study is complete.
Eligibility for the Clinical Trial
To participate in the clinical trial, patients must meet certain criteria. Some key inclusion criteria are: Age between 18 and 80 years Diagnosed with functional cardiovascular disorders (with or without sleeping disorders) Medium severity of FCD symptoms (scoring at least 4 out of 10 on a visual analog scale) Willing and able to follow the trial procedures for the entire duration There are also several exclusion criteria, such as: Known organic cause for the cardiovascular symptoms Pregnancy or breastfeeding Certain existing heart conditions or other serious health issues Known allergies to the ingredients in Cardiodoron® Dilution A healthcare professional can provide more detailed information about eligibility for the trial.
Endpoints of the Study
The clinical trial aims to measure several outcomes, called endpoints. Some of the primary endpoints include: Changes in FCD severity as measured by a visual analog scale Changes in symptom scores using standardized questionnaires Changes in quality of life measures Proportion of patients with improved blood pressure readings Patient and investigator satisfaction with the treatment Changes in sleep quality These endpoints will help researchers determine how effective Cardiodoron® Dilution is compared to a placebo in treating functional cardiovascular disorders.
Safety Considerations
As with any medication, safety is a crucial aspect of the clinical trial. The study will monitor: The number, nature, severity, and seriousness of any adverse events Changes in laboratory blood tests The number of patients who stop treatment due to side effects Patient and investigator satisfaction with the tolerability of the medication It's important to note that while Cardiodoron® Dilution is already in use, this clinical trial will provide more comprehensive data on its safety profile.
If you're interested in learning more about Cardiodoron® Dilution or the ongoing clinical trial, it's best to consult with a healthcare professional who can provide personalized advice based on your individual health situation.