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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01581034
First received: April 16, 2012
Last updated: July 31, 2013
Last verified: July 2013

April 16, 2012
July 31, 2013
April 2012
May 2013   (final data collection date for primary outcome measure)
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
Endothelial function [ Time Frame: At completion of the study, expected to be at 6 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01581034 on ClinicalTrials.gov Archive Site
  • 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
  • Autonomic nervous system [ Time Frame: At completion of the study, expected to be at 6 weeks ] [ Designated as safety issue: No ]
  • Biomarkers in blood [ Time Frame: At completion of the study, expected to be at 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of PADMA 28 on Endothelial Function, Autonomic Nervous System and Biomarkers in Patients With Coronary Artery Disease
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Coronary Artery Disease
  • 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.
  • Drug: Placebo
    3 times 2 capsules per day (30min to 1h before breakfast, lunch and dinner) of placebo will be taken. One capsule contains 403mg.
  • Active Comparator: Padma
    Intervention: Drug: PADMA 28
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01581034
146/11
Yes
University Hospital Inselspital, Berne
University Hospital Inselspital, Berne
Not Provided
Study Chair: Hugo Saner, Prof. Dr. Department of cardiovascular prevention and rehabilitation, Bern University Hospital
University Hospital Inselspital, Berne
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP