Homoeopathic Association in Aortic Valve Surgery (OMEO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00774293
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : October 17, 2008
Hospices Civils de Lyon
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Brief 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.

Condition or disease Intervention/treatment Phase
Aortic Valve Replacement Drug: placebo Drug: Arnica and Bryonia Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preliminary Study of a Homoeopathic Association in Patients Undergoing Aortic Valve Surgery.
Study Start Date : September 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Arnica 5CH and Bryonia 9CH (homeopathic drugs)
Drug: Arnica and Bryonia
Arnica 5CH granules, 5 per day plus Bryonia 5CH Granules, 5 per day for 5 days
Placebo Comparator: 2
placebo Arnica 5CH and Bryonia 9CH
Drug: placebo
5 placebo granules for Arnica 5 CH and 5 placebo granules for Bryonia 5 CH

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00774293

Anaesthesy service, Louis Pradel Hospital
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Jean-Jacques Lehot, MD Hospices Civils de Lyon, Lyon, France

Responsible Party: Philipe Belon, Boiron Identifier: NCT00774293     History of Changes
Other Study ID Numbers: Boiron 041052
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: October 2008

Keywords provided by BOIRON:
Homoeopathic treatment,
heart surgery,
randomized clinical trial