Anaesthesy service, Louis Pradel Hospital
Lyon, 69003, France
NCT Number: NCT00774293
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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Notify Me18 year and older
All sexes
Interventional
Phase 4
Lyon, 69003, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 placebo granules for Arnica 5 CH and 5 placebo granules for Bryonia 5 CH
Arnica 5CH granules, 5 per day plus Bryonia 5CH Granules, 5 per day for 5 days
Time frame: At drain removal
Time frame: Day 2 and Day 7
Time frame: Day 2
Time frame: Closure of thorax
Time frame: Day 7
Time frame: To day 7
Time frame: Day 7
Time frame: 48 hours
Time frame: 48 hours
Time frame: Day 7
Time frame: 30 days
BOIRON
Industry
Preliminary Study of a Homoeopathic Association in Patients Undergoing Aortic Valve Surgery.
Acronym: OMEO
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