Aortic Valve Replacement Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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