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NCT Number: NCT01581034

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Swiss Cardiovascular Prevention and Rehabilitation Center, Bern University Hospital

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Autonomic nervous system

    Time frame: At completion of the study, expected to be at 6 weeks

    Cardiac autonomic tone (expressed as frequency domain parameters of heart rate variability (HRV) & measured by ECG)

  2. Biomarkers in blood

    Time frame: At completion of the study, expected to be at 6 weeks

    Blood inflammatory and anticoagulative biomarkers, measured by fasting blood samples

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study 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

Acronym: PADMA 28

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 19, 2012
Registry last updated
Aug 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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