Effect of PADMA 28 on Endothelial Function, Autonomic Nervous System and Biomarkers in Patients With Coronary Artery Disease
NCT ID: NCT01581034
Last Updated: 2013-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2012-04-30
2013-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Padma
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
Placebo
3 times 2 capsules per day (30min to 1h before breakfast, lunch and dinner) of placebo will be taken. One capsule contains 403mg.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
MALE
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Hugo Saner, Prof. Dr.
Role: STUDY_CHAIR
Department of cardiovascular prevention and rehabilitation, Bern University Hospital
Locations
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Swiss Cardiovascular Prevention and Rehabilitation Center, Bern University Hospital
Bern, , Switzerland
Countries
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References
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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.
Other Identifiers
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146/11
Identifier Type: -
Identifier Source: org_study_id