Trial | NCT00774293  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    92
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.
Study Started
Sep 30
2004
Primary Completion
Jun 30
2007
Study Completion
Aug 31
2007
Last Update
Oct 17
2008
Estimate

Drug placebo

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

Drug Arnica and Bryonia [arnica, bryonia]

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

1 Experimental

Arnica 5CH and Bryonia 9CH (homeopathic drugs)

2 Placebo Comparator

placebo Arnica 5CH and Bryonia 9CH

Criteria 

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.
No Results Posted