Homeopathy for Prevention of Atrial Fibrillation After Aortocoronary Bypass Surgery

August 15, 2018 updated by: Michael Frass, Medical University of Vienna
After heart surgery, about 30% of patients suffer from atrial fibrillation. Patients are randomized into two groups receiving either potentized Strychnos Nux vomica or placebo under double blind conditions. Postoperatively, ECGs are done to monitor cardiac rhythm.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Preoperatively, patients receive potentized Nux vomica or placebo sublingually. Then, patients are observed regarding atrial fibrillation postsurgical. The difference between the group of patients with and without nux vomica is recorded.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A1090
        • Dept Surgery, Med Univ Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients before elective Heart valve - or aortocoronary by pass surgery with heart-lung-machine.

Exclusion Criteria:

  • Pregnant patients
  • Patients with preoperative atrial fibrillation and/or hyperthyreosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo globules group
Patients receive Placebo globules made out of sugar and looking similar to active drug sublingually before surgery.
Drug: Placebo (placebo comparator)
Patients receive Placebo looking similar to active drug
Other Names:
  • Placebo globules
Active Comparator: Nux vomica group
Patients receive Nux vomica globules made out of sugar sublingually before surgery.
Drug: Nux vomica (active comparator)
Patients receive Nux vomica in a homeopathic potentiation
Other Names:
  • Strychnos Nux vomica C200

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of atrial fibrillation after heart surgery with heart lung machine
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Michael Frass, MD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

March 12, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (Estimate)

March 13, 2009

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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