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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
PADMA 28
Placebo
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring endothelial function, biomarkers, autonomic nervous system, coronary artery disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Swiss Cardiovascular Prevention and Rehabilitation Center, Bern University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Padma

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Endothelial function
Expressed as Reactive Hyperemic Index (RHI), measured by non-invasive peripheral arterial tonometry

Secondary Outcome Measures

Autonomic nervous system
Cardiac autonomic tone (expressed as frequency domain parameters of heart rate variability (HRV) & measured by ECG)
Biomarkers in blood
Blood inflammatory and anticoagulative biomarkers, measured by fasting blood samples

Full Information

First Posted
April 16, 2012
Last Updated
July 31, 2013
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT01581034
Brief Title
Effect of PADMA 28 on Endothelial Function, Autonomic Nervous System and Biomarkers in Patients With Coronary Artery Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
endothelial function, biomarkers, autonomic nervous system, coronary artery disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Padma
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PADMA 28
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 times 2 capsules per day (30min to 1h before breakfast, lunch and dinner) of placebo will be taken. One capsule contains 403mg.
Primary Outcome Measure Information:
Title
Endothelial function
Description
Expressed as Reactive Hyperemic Index (RHI), measured by non-invasive peripheral arterial tonometry
Time Frame
At completion of the study, expected to be at 6 weeks
Secondary Outcome Measure Information:
Title
Autonomic nervous system
Description
Cardiac autonomic tone (expressed as frequency domain parameters of heart rate variability (HRV) & measured by ECG)
Time Frame
At completion of the study, expected to be at 6 weeks
Title
Biomarkers in blood
Description
Blood inflammatory and anticoagulative biomarkers, measured by fasting blood samples
Time Frame
At completion of the study, expected to be at 6 weeks

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo Saner, Prof. Dr.
Organizational Affiliation
Department of cardiovascular prevention and rehabilitation, Bern University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Swiss Cardiovascular Prevention and Rehabilitation Center, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25208904
Citation
Schafer D, Lambrecht J, Radtke T, Wilhelm M, Saner H. Effect of a Tibetan herbal mixture on microvascular endothelial function, heart rate variability and biomarkers of inflammation, clotting and coagulation. Eur J Prev Cardiol. 2015 Aug;22(8):1043-5. doi: 10.1177/2047487314544985. Epub 2014 Sep 10.
Results Reference
derived

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

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