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

July 31, 2013 updated by: University Hospital Inselspital, Berne

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.

Study Overview

Status

Completed

Conditions

Intervention / 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

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Swiss Cardiovascular Prevention and Rehabilitation Center, Bern University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At completion of the study, expected to be at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At completion of the study, expected to be at 6 weeks
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
At completion of the study, expected to be at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Study Chair: Hugo Saner, Prof. Dr., Department of cardiovascular prevention and rehabilitation, Bern University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

April 16, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimate)

April 19, 2012

Study Record Updates

Last Update Posted (Estimate)

August 1, 2013

Last Update Submitted That Met QC Criteria

July 31, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 146/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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