In short
This article provides information about ongoing clinical trials for cardiovascular somatic symptom disorder, a condition where patients experience heart-related symptoms without structural heart disease. Currently, there is 1 clinical trial actively recruiting patients to evaluate potential treatments for this condition.
Clinical trial locations
- Germany
Study on the Effects of Cardiodoron Dilution for Patients with Functional Cardiovascular Disorders
This clinical trial is being conducted in Germany and focuses on evaluating a treatment called Cardiodoron® for patients experiencing functional cardiovascular disorders. These are conditions where the heart and blood vessels cause symptoms like irregular heartbeats, dizziness, chest discomfort, and variations in blood pressure, but without any structural damage to the heart itself.
Main inclusion criteria: The trial is open to both men and women between 18 and 80 years of age who have functional cardiovascular disorders of medium severity, defined as a score of 4 or higher on a 10-point scale. Participants may or may not have sleeping problems related to their condition. Women of childbearing potential must use highly effective birth control methods during the study. All participants must be willing and able to follow the trial procedures for its entire duration and must provide informed consent before any trial activities begin.
Main exclusion criteria: The trial excludes patients with severe structural heart problems that go beyond functional disorders. Pregnant or breastfeeding women cannot participate. Patients with a history of allergic reactions to the study medication, those currently enrolled in another clinical trial, or those with any medical condition that doctors believe might make participation unsafe are also excluded. Additionally, patients who are unable to follow study procedures or instructions cannot take part.
Focus and goal: The primary goal of this study is to determine how well Cardiodoron® works in improving symptoms of functional cardiovascular disorders and to assess its safety profile. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers will know who receives the actual treatment versus the placebo until the study concludes. This design helps ensure unbiased results. The trial will last 89 days, during which participants will have regular check-ups to monitor changes in their symptoms, blood pressure, quality of life, and overall health. Researchers will also collect feedback on patient satisfaction with the treatment to evaluate its overall effectiveness and tolerability.
Investigational drug: The medication being studied is Cardiodoron®, an oral solution made from natural ingredients including Onopordum acanthium and Primula veris, combined with a small amount of Hyoscyamus. It is administered as oral drops and is being evaluated in a phase IV clinical trial. Cardiodoron® is believed to work by modulating cardiovascular function, although the exact mechanism is still under investigation. The trial aims to identify suitable ways to measure the treatment's success and any potential side effects.
Summary
Currently, there is one active clinical trial investigating treatments for cardiovascular somatic symptom disorder. The trial is being conducted in Germany and focuses on evaluating Cardiodoron®, a natural ingredient-based oral solution, compared to placebo. The study is designed to assess both the effectiveness and safety of this treatment in patients experiencing functional cardiovascular symptoms without structural heart disease. The trial is open to adults aged 18 to 80 with moderate severity symptoms and follows a rigorous double-blind design to ensure reliable results. Patients interested in participating should meet the specific inclusion criteria and be willing to commit to the 89-day trial duration with regular follow-up visits.
