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

NCT01581034 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-08-01

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Switzerland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01581034 on ClinicalTrials.gov