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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Endothelial function
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Padma
Intervention: PADMA 28 (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Endothelial function
Time Frame: 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 Outcomes
- Autonomic nervous system(At completion of the study, expected to be at 6 weeks)
- Biomarkers in blood(At completion of the study, expected to be at 6 weeks)