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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Placebo-controlled, Double-blinded Trial on the Effect of PADMA 28 on Endothelial Function, Biomarkers and the Autonomic Nervous System in Patients With Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: PADMA 28
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Padma<br> | Drug: PADMA 28<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 3 times 2 capsules per day (30min to 1h before breakfast, lunch and dinner) of placebo will be taken. One capsule contains 403mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Expressed as Reactive Hyperemic Index (RHI), measured by non-invasive peripheral arterial tonometry | At completion of the study, expected to be at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic nervous system | Cardiac autonomic tone (expressed as frequency domain parameters of heart rate variability (HRV) & measured by ECG) | At completion of the study, expected to be at 6 weeks | 
| Biomarkers in blood | Blood inflammatory and anticoagulative biomarkers, measured by fasting blood samples | At completion of the study, expected to be at 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function, biomarkers, autonomic nervous system, coronary artery disease