Effect of PADMA 28 on Endothelial Function, Autonomic Nervous System and Biomarkers in Patients With Coronary Artery Disease
- Registration Number
- NCT01581034
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Padma PADMA 28 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Swiss Cardiovascular Prevention and Rehabilitation Center, Bern University Hospital
🇨ðŸ‡Bern, Switzerland