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

Coronary Artery Disease Clinical Trial

— PADMA 28  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581034
• Other study ID #: 146/11
• Status: Completed
• Phase: Phase 2
• First received: April 16, 2012
• Last updated: July 31, 2013
• Start date: April 2012
• Est. completion date: May 2013

Study information

• Verified date: July 2013
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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
3 times 2 capsules per day (30min to 1h before breakfast, lunch and dinner) of placebo will be taken. One capsule contains 403mg.

Locations

Country	Name	City	State
Switzerland	Swiss Cardiovascular Prevention and Rehabilitation Center, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function	Expressed as Reactive Hyperemic Index (RHI), measured by non-invasive peripheral arterial tonometry	At completion of the study, expected to be at 6 weeks	No
Secondary	Autonomic nervous system	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	No
Secondary	Biomarkers in blood	Blood inflammatory and anticoagulative biomarkers, measured by fasting blood samples	At completion of the study, expected to be at 6 weeks	No