Effect of PADMA 28 on Endothelial Function, Autonomic Nervous System and Biomarkers in Patients With Coronary Artery Disease
Effect of PADMA 28 on Endothelial Function, Autonomic Nervous System and Biomarkers in Patients With Coronary Artery Disease
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.
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.
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