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CompletedNCT00774293OMEOUpdated Oct 17, 2008

Homoeopathic Association in Aortic Valve Surgery

A Phase 4 interventional study of placebo and Arnica and Bryonia in Aortic Valve Replacement, sponsored by BOIRON. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-17.

Sponsored by BOIRON · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Aortic Valve Replacement

Keywords

  • Homoeopathic treatment,
  • heart surgery,
  • randomized clinical trial
03

In context

Lead sponsor

This is the only study on the registry with BOIRON as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients over 18 years, undergoing aortic valve surgery with extra corporeal circulation

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    1

    Arnica 5CH and Bryonia 9CH (homeopathic drugs)

    Drug: Arnica and Bryonia

  • Placebo comparator
    2

    placebo Arnica 5CH and Bryonia 9CH

    Drug: placebo

Interventions

  • Drugplacebo

    5 placebo granules for Arnica 5 CH and 5 placebo granules for Bryonia 5 CH

  • DrugArnica and Bryonia

    Drug page: Arnicae flos extract

    Arnica 5CH granules, 5 per day plus Bryonia 5CH Granules, 5 per day for 5 days

06

What researchers measure

Primary outcomes

  1. Amount of drained liquid from the mediastinum or the pleura

    Time frame: At drain removal

  2. plasma C reactive protein (CRP) at anaesthesia induction, plasma C reactive protein (CRP)

    Time frame: Day 2 and Day 7

Secondary outcomes

  1. Evolution of body temperature from before surgery to day 2 after surgery.

    Time frame: Day 2

  2. Time from the end of extra corporeal circulation to closure of the thorax,

    Time frame: Closure of thorax

  3. Amount of transfusions of erythrocytes, platelets, plasma.

    Time frame: Day 7

  4. 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

  5. Amount of analgesic drugs, paracetamol and morphine.

    Time frame: Day 7

  6. EKG before surgery, 24 and 48 hours after surgery.

    Time frame: 48 hours

  7. Plasma troponin I at induction of anaesthesia, 6, 24 and 48 hours after surgery.

    Time frame: 48 hours

  8. Quality of cicatrisation of sternotomy immediately after surgery, at day 2 and 7 after surgery, on a 4 point scale.

    Time frame: Day 7

  9. 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

07

Study locations

1 site
  • Anaesthesy service, Louis Pradel Hospital
    Lyon, 69003, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2004, a primary completion of Jun 2007 and a completion of Aug 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2008
First posted
Oct 17, 2008
Start
Sep 2004
Primary completionActual
Jun 2007
CompletionActual
Aug 2007
Last update
Oct 17, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00774293
Lead sponsor
BOIRON
Collaborators
Hospices Civils de Lyon
First posted
Oct 17, 2008
Start date
Sep 2004
Primary completion
Jun 2007
Completion
Aug 2007
Last update
Oct 17, 2008

Study contacts

Jean-Jacques Lehot, MD
principal investigator · Hospices Civils de Lyon, Lyon, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Arnicae flos extract

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