Homeopathy for Prevention of Atrial Fibrillation After Aortocoronary Bypass Surgery
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Nux vomica (active comparator)
Placebo (placebo comparator)
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Nux vomica, homeopathy, heart lung machine, heart surgery, postoperatively studied
Eligibility Criteria
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
Sites / Locations
- Dept Surgery, Med Univ Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo globules group
Nux vomica group
Arm Description
Patients receive Placebo globules made out of sugar and looking similar to active drug sublingually before surgery.
Patients receive Nux vomica globules made out of sugar sublingually before surgery.
Outcomes
Primary Outcome Measures
Frequency of atrial fibrillation after heart surgery with heart lung machine
Secondary Outcome Measures
Full Information
NCT ID
NCT00861237
First Posted
March 12, 2009
Last Updated
August 15, 2018
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00861237
Brief Title
Homeopathy for Prevention of Atrial Fibrillation After Aortocoronary Bypass Surgery
Official Title
Homeopathy for Prevention of Atrial Fibrillation After Aortocoronary Bypass Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Number of patients recruited to small, no cooperation of study members
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Nux vomica, homeopathy, heart lung machine, heart surgery, postoperatively studied
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo globules group
Arm Type
Placebo Comparator
Arm Description
Patients receive Placebo globules made out of sugar and looking similar to active drug sublingually before surgery.
Arm Title
Nux vomica group
Arm Type
Active Comparator
Arm Description
Patients receive Nux vomica globules made out of sugar sublingually before surgery.
Intervention Type
Drug
Intervention Name(s)
Nux vomica (active comparator)
Other Intervention Name(s)
Strychnos Nux vomica C200
Intervention Description
Patients receive Nux vomica in a homeopathic potentiation
Intervention Type
Drug
Intervention Name(s)
Placebo (placebo comparator)
Other Intervention Name(s)
Placebo globules
Intervention Description
Patients receive Placebo looking similar to active drug
Primary Outcome Measure Information:
Title
Frequency of atrial fibrillation after heart surgery with heart lung machine
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Frass, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept Surgery, Med Univ Vienna
City
Vienna
ZIP/Postal Code
A1090
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Homeopathy for Prevention of Atrial Fibrillation After Aortocoronary Bypass Surgery
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