Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Padma | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PADMA 28 | Drug | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hugo Saner, Prof. Dr. | Department of cardiovascular prevention and rehabilitation, Bern University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Cardiovascular Prevention and Rehabilitation Center, Bern University Hospital | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25208904 | Derived | Schafer D, Lambrecht J, Radtke T, Wilhelm M, Saner H. Effect of a Tibetan herbal mixture on microvascular endothelial function, heart rate variability and biomarkers of inflammation, clotting and coagulation. Eur J Prev Cardiol. 2015 Aug;22(8):1043-5. doi: 10.1177/2047487314544985. Epub 2014 Sep 10. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C066069 | Padma 28 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 3 times 2 capsules per day (30min to 1h before breakfast, lunch and dinner) of placebo will be taken. One capsule contains 403mg. |
|
Blood inflammatory and anticoagulative biomarkers, measured by fasting blood samples
| At completion of the study, expected to be at 6 weeks |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |