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Sponsors and Collaborators: |
BOIRON Hospices Civils de Lyon |
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Information provided by: | BOIRON |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention | Phase |
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Aortic Valve Replacement |
Drug: placebo Drug: Arnica and Bryonia |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Preliminary Study of a Homoeopathic Association in Patients Undergoing Aortic Valve Surgery. |
Enrollment: | 92 |
Study Start Date: | September 2004 |
Study Completion Date: | August 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Arnica 5CH and Bryonia 9CH (homeopathic drugs)
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Drug: Arnica and Bryonia
Arnica 5CH granules, 5 per day plus Bryonia 5CH Granules, 5 per day for 5 days
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2: Placebo Comparator
placebo Arnica 5CH and Bryonia 9CH
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Drug: placebo
5 placebo granules for Arnica 5 CH and 5 placebo granules for Bryonia 5 CH
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Anaesthesy service, Louis Pradel Hospital | |
Lyon, France, 69003 |
Principal Investigator: | Jean-Jacques Lehot, MD | Hospices Civils de Lyon, Lyon, France |
Responsible Party: | Boiron ( Philipe Belon ) |
Study ID Numbers: | Boiron 041052 |
Study First Received: | October 16, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00774293 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Homoeopathic treatment, heart surgery, randomized clinical trial |