Effect of PADMA 28 on Endothelial Function, Autonomic Nervous System and Biomarkers in Patients With Coronary Artery Disease
PADMA 28
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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 coronary-artery-disease
Started Apr 2012
Shorter than P25 for phase_2 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 16, 2012
CompletedFirst Posted
Study publicly available on registry
April 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedAugust 1, 2013
July 1, 2013
1.1 years
April 16, 2012
July 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Autonomic nervous system
At completion of the study, expected to be at 6 weeks
Biomarkers in blood
At completion of the study, expected to be at 6 weeks
Study Arms (2)
Padma
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
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.
3 times 2 capsules per day (30min to 1h before breakfast, lunch and dinner) of placebo will be taken. One capsule contains 403mg.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Swiss Cardiovascular Prevention and Rehabilitation Center, Bern University Hospital
Bern, 3010, Switzerland
Related Publications (1)
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.
PMID: 25208904DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hugo Saner, Prof. Dr.
Department of cardiovascular prevention and rehabilitation, Bern University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2012
First Posted
April 19, 2012
Study Start
April 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
August 1, 2013
Record last verified: 2013-07