Coronary Artery Disease
Conditions
Keywords
endothelial function, biomarkers, autonomic nervous system, coronary artery disease
Brief summary
This randomized, placebo-controlled, double-blinded trial investigates the effect of a 6 week intake of PADMA 28 on the endothelial function, biomarkers and the autonomic nervous systems in patients with coronary artery disease. The investigators hypothesize that PADMA 28 has a beneficial effect on endothelial function, arterial stiffness, the autonomic nervous systen and the blood inflammatory markers in patients with coronary artery disease compared to placebo treatment.
Detailed description
Background This randomized, placebo-controlled, double-blinded trial investigates the effect of a 6 week intake of PADMA 28 on the endothelial function, biomarkers and the autonomic nervous systems in patients with coronary artery disease. PADMA 28 contains 20 herbs from Tibet. The endothelial function will be measured by EndoPAT 2000, the autonomic nervous system by an ambulatory electrocardiography during the orthostatic reaction and the biomarkers will be analyzed with taking a blood sample. The investigators hypothesize that PADMA 28 has a beneficial effect on endothelial function, arterial stiffness, the autonomic nervous systen and the blood inflammatory markers in patients with coronary artery disease compared to placebo treatment. Objective To assess the effect of PADMA 28 on endothelial function, autonomic nervous system and biomarkers in patients with coronary artery disease. Methods 80 patients with coronary artery disease will be recruited for the study. To measure endothelial function, the investigators use EndoPAT 2000. The autonomic nervous system will be analysed with ambulatory electrocardiography.
Interventions
DRUGPADMA 28
PADMA 28 is a biological drug registered in Switzerland. It contains 20 herbs from Tibet. 3 times 2 capsules per day (30min to 1h before breakfast, lunch and dinner) of PADMA 28 or placebo will be taken. One capsule contains 403mg.
DRUGPlacebo
3 times 2 capsules per day (30min to 1h before breakfast, lunch and dinner) of placebo will be taken. One capsule contains 403mg.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Male patient with coronary artery disease * Stable medication * Physically stable * Psychologically stable * Written informed consent * Willing and able to comply with all trial requirements * Must have completed rehabilitation program since at least 6 months and no longer than 5 years prior to study begin
Exclusion criteria
* Acute coronary syndrome within the last three months * Abnormal high hepatic enzymes * Renal insufficiency with compensated retention * Intake of medication which may affect endothelial function * Currently smoking * Current malignant diseases, which may reduce the expectancy of life * Chronic heart failure * Insulin-dependent diabetes * Known hypersensitivity against any ingredient of PADMA 28 * Longterm intake of supplements * Serious mental health issues * Alcohol and/or drug abuse * Simultaneous participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function | At completion of the study, expected to be at 6 weeks | Expressed as Reactive Hyperemic Index (RHI), measured by non-invasive peripheral arterial tonometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Autonomic nervous system | At completion of the study, expected to be at 6 weeks | Cardiac autonomic tone (expressed as frequency domain parameters of heart rate variability (HRV) & measured by ECG) |
| Biomarkers in blood | At completion of the study, expected to be at 6 weeks | Blood inflammatory and anticoagulative biomarkers, measured by fasting blood samples |
Countries
Switzerland
Outcome results
None listed