NCT00774293

Homoeopathic Association in Aortic Valve Surgery

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: BOIRON · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Replacement

Interventions

Type	Name	Description
DRUG	placebo	5 placebo granules for Arnica 5 CH and 5 placebo granules for Bryonia 5 CH
DRUG	Arnica and Bryonia	Arnica 5CH granules, 5 per day plus Bryonia 5CH Granules, 5 per day for 5 days

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-06-01
• Completion: 2007-08-01
• First posted: 2008-10-17
• Last updated: 2008-10-17

Locations

1 site across 1 country: France