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Completed

NCT Number: NCT00774293

Homoeopathic Association in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anaesthesy service, Louis Pradel Hospital

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

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

Arnica and Bryonia

Drug

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

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

Sponsors and collaborators

Lead sponsor

BOIRON

Industry

Collaborators

  • Hospices Civils de Lyon

Registry information

Official study title

Preliminary Study of a Homoeopathic Association in Patients Undergoing Aortic Valve Surgery.

Acronym: OMEO

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Oct 17, 2008
Registry last updated
Oct 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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