In short
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.
At a glance
- 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
What is Cardiodoron®?
Cardiodoron® Dilution is an anthroposophic medicinal product used to treat certain heart and circulatory system disorders. 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.
What Medical Conditions Does Cardiodoron® Treat?
Cardiodoron® is primarily used to treat functional cardiovascular disorders (FCD). 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. FCDs with or without sleeping disorders: Some patients may also experience sleep problems along with their cardiovascular symptoms.
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 extract from the flower of Onopordum acanthium (cotton thistle) combined with a small amount of Hyoscyamus (henbane). 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. These ingredients are prepared using a special process called "ethanol digestio," which is a method of extracting active compounds from plants using alcohol.
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. 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. 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. 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. Conducted at a single center in Germany.
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. Presence of functional cardiovascular disorders with or without sleeping disorders. Medium FCD severity (Visual Analog Scale score ≥ 4 out of 10). Some exclusion criteria include: Known organic cause of complaints. Pregnant or lactating women. Patients with certain existing cardiac diseases or other severe health conditions.
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. Determine how much of an effect Cardiodoron® has compared to a placebo. Evaluate the safety of Cardiodoron®.
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. Improvements in quality of life. Effects on blood pressure. Improvements in sleep quality. Patient and investigator satisfaction with the treatment. Any side effects or adverse events that occur during the trial.
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.