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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment called Cardiodoron® in patients with functional cardiovascular disorders. These disorders affect the heart and blood vessels, causing symptoms like irregular heartbeats or chest discomfort, but without any structural heart disease. The treatment being tested is an oral solution made from natural ingredients, including Onopordum acanthium and Primula veris, combined with a small amount of Hyoscyamus. The study will compare the effects of Cardiodoron® with a placebo to understand its effectiveness and safety.

The purpose of the study is to determine how well Cardiodoron® works in improving symptoms of functional cardiovascular disorders and to assess its safety. Participants will be randomly assigned to receive either the Cardiodoron® treatment or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The trial will last for a period of 89 days, during which participants will be monitored for changes in their symptoms and overall health.

Throughout the study, participants will have regular check-ups to track their progress and any changes in their condition. The researchers aim to identify suitable ways to measure the treatment's success and any potential side effects. By the end of the study, the goal is to have a clear understanding of how Cardiodoron® can benefit those with functional cardiovascular disorders and to ensure it is safe for use. Participants' feedback on their satisfaction with the treatment will also be collected to help evaluate its overall effectiveness and tolerability.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age (18 to 80 years), presence of functional cardiovascular disorders (FCD), and ability to follow trial procedures.
Informed consent is signed before any trial-related activities begin.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements. This includes evaluating the severity of FCD using a visual analog scale (VAS) and other health assessments.
Step 3
Medication administration
Participants are randomly assigned to receive either Cardiodoron® or a placebo. Both are administered as oral drops.
The dosage and frequency of administration are determined by the study protocol and are followed throughout the trial duration.
Step 4
Follow-up visits
Regular follow-up visits are scheduled to monitor progress and collect data on FCD severity, symptom scores, and quality of life.
These visits include assessments at specific intervals, such as V3 and V4, to evaluate changes from baseline.
Step 5
Final assessment
At the end of the trial, a final assessment is conducted to measure outcomes such as blood pressure, symptom improvement, and overall satisfaction with the treatment.
Any adverse events or changes in laboratory parameters are also reviewed.
Step 6
Completion of the trial
The trial concludes with a review of all collected data to determine the efficacy and safety of Cardiodoron® compared to the placebo.
Participants are informed of the study's findings and any further steps, if applicable.

Who can join the trial?

6 criteria

Patients of all sexes aged between 18 and 80 years old.
Must have **functional cardiovascular disorders** (FCD), which may or may not include sleeping problems.
FCD should be of medium severity, which means a score of 4 or more out of 10 on a scale called **VAS** (Visual Analogue Scale).
Female patients who can have children must use highly effective birth control methods.
Must be willing and able to follow all the trial assessments and procedures for the entire duration of the trial.
Must sign an informed consent form before any trial-related procedures begin. This means agreeing to participate after understanding the trial details.

Who cannot join the trial?

6 criteria

Patients with severe heart problems that are not just functional disorders.
Patients who are pregnant or breastfeeding.
Patients with a history of allergic reactions to the study medication.
Patients currently participating in another clinical trial.
Patients with any other medical condition that the study doctors think might make it unsafe for them to participate.
Patients who are unable to follow the study procedures or instructions.

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FutureMeds GmbH
Berlin, Germany

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Investigated drugs

Cardiodoron is a medication being studied for its effectiveness and safety in treating functional cardiovascular disorders. The trial aims to determine how well Cardiodoron works compared to a placebo and to assess its safety for patients with these heart-related conditions.

What is already known about the treatment

Cardiodoron – Cardiodoron is administered orally in the form of tablets. It is currently being studied in a phase IV clinical trial to assess its efficacy and safety in treating functional cardiovascular disorders. The main therapeutic indication for Cardiodoron is to manage symptoms associated with these disorders. At the molecular level, Cardiodoron is believed to work by modulating cardiovascular function, although the exact mechanism is still under investigation. It is classified pharmacologically as a cardiovascular agent.

Investigated diseases

Functional Cardiovascular Disorders – These are conditions where the heart and blood vessels do not function properly, but without any structural abnormalities. Symptoms may include palpitations, dizziness, and variations in blood pressure. The progression of these disorders can vary, with symptoms sometimes appearing intermittently or becoming more persistent over time. They are often influenced by stress, lifestyle, and other external factors. Unlike structural heart diseases, these disorders do not involve damage to the heart muscle or valves. Management typically focuses on lifestyle changes and addressing any underlying stressors.