Atrial FibrillationPhase 4NCT00861237
Homeopathy for Prevention of Atrial Fibrillation After Aortocoronary Bypass Surgery
A Phase 4 study testing Nux vomica (active comparator) in people with Atrial Fibrillation, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Nux vomica (active comparator)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2008to Nov 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients before elective Heart valve - or aortocoronary by pass surgery with heart-lung-machine.
Who cannot join
- Pregnant patients
- Patients with preoperative atrial fibrillation and/or hyperthyreosis
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Nux vomica (active comparator), Placebo (placebo comparator)
- Keywords
- Nux vomica, homeopathy, heart lung machine, heart surgery, postoperatively studied
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nux vomica (active comparator)Drug
Also called Strychnos Nux vomica C200
Patients receive Nux vomica in a homeopathic potentiation
Placebo (placebo comparator)Drug
Also called Placebo globules
Patients receive Placebo looking similar to active drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo globules group | Placebo comparator | Patients receive Placebo globules made out of sugar and looking similar to active drug sublingually before surgery. Receives: Drug: Placebo (placebo comparator) |
| Nux vomica group | Active comparator | Patients receive Nux vomica globules made out of sugar sublingually before surgery. Receives: Drug: Nux vomica (active comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of atrial fibrillation after heart surgery with heart lung machine
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startJul 2008
- Primary completionOct 2017
- Study completionNov 2017
Why it stopped: Number of patients recruited to small, no cooperation of study members
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Frass, Medical University of Vienna
- Investigators
- Michael Frass, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861237
- Sponsor's protocol ID
- 2342
- Status last verified
- Aug 2018
- First submitted
- 12 Mar 2009
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homeopathy for Prevention of Atrial Fibrillation After Aortocoronary Bypass Surgery
- ClinicalTrials.gov ID
- NCT00861237
- Acronym / sponsor ID
- 2342
- Conditions
- Atrial Fibrillation
- Keywords
- Nux vomica, homeopathy, heart lung machine, heart surgery, postoperatively studied
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Number of patients recruited to small, no cooperation of study members
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Oct 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo globules group | Placebo comparator | Drug: Placebo (placebo comparator)Patients receive Placebo globules made out of sugar and looking similar to active drug sublingually before surgery. |
| Nux vomica group | Active comparator | Drug: Nux vomica (active comparator)Patients receive Nux vomica globules made out of sugar sublingually before surgery. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients before elective Heart valve - or aortocoronary by pass surgery with heart-lung-machine.
Key exclusion criteria (2 listed)
- Pregnant patients
- Patients with preoperative atrial fibrillation and/or hyperthyreosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nux vomica (active comparator)Also: Strychnos Nux vomica C200Patients receive Nux vomica in a homeopathic potentiation | Drug | Nux vomica group |
| Placebo (placebo comparator)Also: Placebo globulesPatients receive Placebo looking similar to active drug | Drug | Placebo globules group |
Primary outcome
Frequency of atrial fibrillation after heart surgery with heart lung machine
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Number of patients recruited to small, no cooperation of study members). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Frass, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nux vomica (active comparator) in people with Atrial Fibrillation, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Number of patients recruited to small, no cooperation of study members). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of atrial fibrillation after heart surgery with heart lung machine (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.