Aortic Valve ReplacementPhase 4OMEONCT00774293
Homoeopathic Association in Aortic Valve Surgery
A Phase 4 study testing Arnica and Bryonia in people with Aortic Valve Replacement, run by BOIRON at 1 site in France.
Trial summary
Randomized, parallel group, placebo controlled study to assess the effect of an homoeopathic association of Arnica 5 CH et Bryonia 9 CH during aortic valve surgery with extra corporeal circulation, to alleviate inflammation, haemorrhage, myocardial ischemia and pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Replacement
- What is being tested?
- Arnica and Bryonia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2004to Aug 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years, undergoing aortic valve surgery with extra corporeal circulation
Who cannot join
- acute infectious or inflammatory concomitant disease, known allergy to one of the investigational products, Patients who did not sign the study consent form, patients having received during the 3 days before surgery any corticoids or non steroid anti-inflammatory drug, patient undergoing a surgery other than surgery of the aortic valve in the same intervention, patient undergoing an iterative cardiac surgery, patients under 18 years, patient over 18 years under the protection of the law.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Study of a Homoeopathic Association in Patients Undergoing Aortic Valve Surgery.
Randomized, parallel group, placebo controlled study to assess the effect of an homoeopathic association of Arnica 5 CH et Bryonia 9 CH during aortic valve surgery with extra corporeal circulation, to alleviate inflammation, haemorrhage, myocardial ischemia and pain. This is a pilot study; a confirmative study will be set up if this study is positive.
The study treatment will start the day before surgery, and will comprise 5 granules of each homoeopathic medication, Arnica 5 CH and Bryonia 9 CH, or their matching placebo TID during 5 days, in addition to all routine treatments.) Two groups of 45 patients will be included. Patients have to be over 18 years, to undergo aortic valve surgery only, have no known allergy to one of the study drugs, sign a consent form, and must not have received anti inflammatory drug in the 3 days before surgery. The primary criteria include the amount of drained liquid from the chest, and the CRP evolution from baseline to the 7th postoperative day. Secondary criteria address inflammation, haemorrhage, ischaemia, and pain. A follow-up phone call is given to the patients 30 days after their surgery.
- Conditions
- Aortic Valve Replacement
- Being tested
- placebo, Arnica and Bryonia
- Keywords
- Homoeopathic treatment,, heart surgery,, randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
5 placebo granules for Arnica 5 CH and 5 placebo granules for Bryonia 5 CH
Arnica and BryoniaDrug
Arnica 5CH granules, 5 per day plus Bryonia 5CH Granules, 5 per day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Arnica 5CH and Bryonia 9CH (homeopathic drugs) Receives: Drug: Arnica and Bryonia |
| 2 | Placebo comparator | placebo Arnica 5CH and Bryonia 9CH Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of drained liquid from the mediastinum or the pleura
Measured: At drain removal
plasma C reactive protein (CRP) at anaesthesia induction, plasma C reactive protein (CRP)
Measured: Day 2 and Day 7
Secondary outcomes (9)
Evolution of body temperature from before surgery to day 2 after surgery.
Measured: Day 2
Time from the end of extra corporeal circulation to closure of the thorax,
Measured: Closure of thorax
Amount of transfusions of erythrocytes, platelets, plasma.
Measured: Day 7
Visual analogical scale (VAS) for pain every 6 hours during stay in PACU, and every day afterwards to day 7,
Measured: To day 7
Amount of analgesic drugs, paracetamol and morphine.
Measured: Day 7
EKG before surgery, 24 and 48 hours after surgery.
Measured: 48 hours
Plasma troponin I at induction of anaesthesia, 6, 24 and 48 hours after surgery.
Measured: 48 hours
Quality of cicatrisation of sternotomy immediately after surgery, at day 2 and 7 after surgery, on a 4 point scale.
Measured: Day 7
Clinical events: death, new surgery for haemostasis or infection within 2 weeks of surgery, and any event occurring within 30 days after surgery.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startSep 2004
- Primary completionJun 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve ReplacementStudies of the same condition, open and under way.
- 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- BOIRON
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospices Civils de Lyon
- Investigators
- Jean-Jacques Lehot, MD, Principal investigator, Hospices Civils de Lyon, Lyon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774293
- Sponsor's protocol ID
- Boiron 041052
- Acronym
- OMEO
- Status last verified
- Oct 2008
- First submitted
- 16 Oct 2008
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of a Homoeopathic Association in Patients Undergoing Aortic Valve Surgery.
- ClinicalTrials.gov ID
- NCT00774293
- Acronym / sponsor ID
- OMEO / Boiron 041052
- Conditions
- Aortic Valve Replacement
- Keywords
- Homoeopathic treatment,, heart surgery,, randomized clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- BOIRONIndustry (pharma, biotech, devices)
- Collaborators
- Hospices Civils de Lyon
- Study start
- Sep 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 17 Oct 2008 (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.
Randomized, parallel group, placebo controlled study to assess the effect of an homoeopathic association of Arnica 5 CH et Bryonia 9 CH during aortic valve surgery with extra corporeal circulation, to alleviate inflammation, haemorrhage, myocardial ischemia and pain. This is a pilot study; a confirmative study will be set up if this study is positive.
The study treatment will start the day before surgery, and will comprise 5 granules of each homoeopathic medication, Arnica 5 CH and Bryonia 9 CH, or their matching placebo TID during 5 days, in addition to all routine treatments.) Two groups of 45 patients will be included. Patients have to be over 18 years, to undergo aortic valve surgery only, have no known allergy to one of the study drugs, sign a consent form, and must not have received anti inflammatory drug in the 3 days before surgery. The primary criteria include the amount of drained liquid from the chest, and the CRP evolution from baseline to the 7th postoperative day. Secondary criteria address inflammation, haemorrhage, ischaemia, and pain. A follow-up phone call is given to the patients 30 days after their surgery.
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 |
|---|---|---|
| 1 | Experimental | Drug: Arnica and BryoniaArnica 5CH and Bryonia 9CH (homeopathic drugs) |
| 2 | Placebo comparator | Drug: placeboplacebo Arnica 5CH and Bryonia 9CH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years, undergoing aortic valve surgery with extra corporeal circulation
Key exclusion criteria (1 listed)
- acute infectious or inflammatory concomitant disease, known allergy to one of the investigational products, Patients who did not sign the study consent form, patients having received during the 3 days before surgery any corticoids or non steroid anti-inflammatory drug, patient undergoing a surgery other than surgery of the aortic valve in the same intervention, patient undergoing an iterative cardiac surgery, patients under 18 years, patient over 18 years under the protection of the law.
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 |
|---|---|---|
| placebo5 placebo granules for Arnica 5 CH and 5 placebo granules for Bryonia 5 CH | Drug | 2 |
| Arnica and BryoniaArnica 5CH granules, 5 per day plus Bryonia 5CH Granules, 5 per day for 5 days | Drug | 1 |
Primary outcome
Amount of drained liquid from the mediastinum or the pleura
Time frame: At drain removal
plasma C reactive protein (CRP) at anaesthesia induction, plasma C reactive protein (CRP)
Time frame: Day 2 and Day 7
9 secondary outcomes
Evolution of body temperature from before surgery to day 2 after surgery.
Time frame: Day 2
Time from the end of extra corporeal circulation to closure of the thorax,
Time frame: Closure of thorax
Amount of transfusions of erythrocytes, platelets, plasma.
Time frame: Day 7
Visual analogical scale (VAS) for pain every 6 hours during stay in PACU, and every day afterwards to day 7,
Time frame: To day 7
Amount of analgesic drugs, paracetamol and morphine.
Time frame: Day 7
EKG before surgery, 24 and 48 hours after surgery.
Time frame: 48 hours
Plasma troponin I at induction of anaesthesia, 6, 24 and 48 hours after surgery.
Time frame: 48 hours
Quality of cicatrisation of sternotomy immediately after surgery, at day 2 and 7 after surgery, on a 4 point scale.
Time frame: Day 7
Clinical events: death, new surgery for haemostasis or infection within 2 weeks of surgery, and any event occurring within 30 days after surgery.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
Related trials for Aortic Valve Replacement
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Active, not recruiting
The JenaValve ALIGN-AR LVAD Registry
Aortic Regurgitation, Aortic Valve Insufficiency
Active, not recruiting
Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)
Aortic Stenosis With Bicuspid Valve
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.
Jean-Jacques Lehot, MD principal investigator
Hospices Civils de Lyon, Lyon, France
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 Arnica and Bryonia in people with Aortic Valve Replacement, run by BOIRON at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 17 Oct 2008. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amount of drained liquid from the mediastinum or the pleura (time frame: At drain removal). The study lists 2 primary outcomes in all. 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 17 Oct 2008.