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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01581034
First received: April 16, 2012
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
 Drug: PADMA 28
Drug: Placebo
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 80
Study Start Date: April 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.

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

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male patient with coronary artery disease
  • Stable medication
  • Physically stable
  • Psychologically stable
  • Willing and able to comply

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
  • Malignant diseases
  • Chronic heart failure
  • Insulin-dependent diabetes
  • Hypersensitivity against any ingredient of PADMA 28
  • Longterm intake of supplements
  • Serious mental health issue
  • Alcohol and/or drug abuse
  • Simultaneous participation in another clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581034

Locations
Switzerland
Swiss Cardiovascular Prevention and Rehabilitation Center, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Chair: Hugo Saner, Prof. Dr. Department of cardiovascular prevention and rehabilitation, Bern University Hospital
  More Information

No publications provided

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01581034     History of Changes
Other Study ID Numbers: 146/11
Study First Received: April 16, 2012
Last Updated: May 2, 2013
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:
endothelial function
biomarkers
autonomic nervous system
coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013