Homeopathy for Prevention of Atrial Fibrillation After Aortocoronary Bypass Surgery

NCT ID: NCT00861237

Last Updated: 2018-08-16

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo globules group

Patients receive Placebo globules made out of sugar and looking similar to active drug sublingually before surgery.

Group Type PLACEBO_COMPARATOR

Placebo (placebo comparator)

Intervention Type DRUG

Patients receive Placebo looking similar to active drug

Nux vomica group

Patients receive Nux vomica globules made out of sugar sublingually before surgery.

Group Type ACTIVE_COMPARATOR

Nux vomica (active comparator)

Intervention Type DRUG

Patients receive Nux vomica in a homeopathic potentiation

Interventions

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Nux vomica (active comparator)

Patients receive Nux vomica in a homeopathic potentiation

Intervention Type DRUG

Placebo (placebo comparator)

Patients receive Placebo looking similar to active drug

Intervention Type DRUG

Other Intervention Names

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Strychnos Nux vomica C200 Placebo globules

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Michael Frass

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Frass, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Dept Surgery, Med Univ Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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2342

Identifier Type: -

Identifier Source: org_study_id

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