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

Insel Gruppe AG, University Hospital Bern

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease

Treatments: Drug: PADMA 28; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01581034

146/11

Details and patient eligibility

About

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.

Full 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

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.

Enrollment: 80 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Padma

Active Comparator group

Treatment:

Drug: PADMA 28

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo