Effect of PADMA 28 on Endothelial Function, Autonomic Nervous System and Biomarkers in Patients With Coronary Artery Disease (PADMA 28)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||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|
- Endothelial function [ Time Frame: At completion of the study, expected to be at 6 weeks ] [ Designated as safety issue: No ]Expressed as Reactive Hyperemic Index (RHI), measured by non-invasive peripheral arterial tonometry
- Autonomic nervous system [ Time Frame: At completion of the study, expected to be at 6 weeks ] [ Designated as safety issue: No ]Cardiac autonomic tone (expressed as frequency domain parameters of heart rate variability (HRV) & measured by ECG)
- Biomarkers in blood [ Time Frame: At completion of the study, expected to be at 6 weeks ] [ Designated as safety issue: No ]Blood inflammatory and anticoagulative biomarkers, measured by fasting blood samples
|Study Start Date:||April 2012|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Padma||
Drug: PADMA 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.
|Placebo Comparator: Placebo||
3 times 2 capsules per day (30min to 1h before breakfast, lunch and dinner) of placebo will be taken. One capsule contains 403mg.
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.
To assess the effect of PADMA 28 on endothelial function, autonomic nervous system and biomarkers in patients with coronary artery disease.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581034
|Swiss Cardiovascular Prevention and Rehabilitation Center, Bern University Hospital|
|Bern, Switzerland, 3010|
|Study Chair:||Hugo Saner, Prof. Dr.||Department of cardiovascular prevention and rehabilitation, Bern University Hospital|