Homoeopathic Association in Aortic Valve Surgery - Full Text View

Sponsors and Collaborators:	BOIRON Hospices Civils de Lyon
Information provided by:	BOIRON
ClinicalTrials.gov Identifier:	NCT00774293

Purpose

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
Aortic Valve Replacement	Drug: placebo Drug: Arnica and Bryonia	Phase IV

Drug Information available for: Arnica extract

U.S. FDA Resources

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.

Further study details as provided by BOIRON:

Primary Outcome Measures:

Amount of drained liquid from the mediastinum or the pleura [ Time Frame: At drain removal ] [ Designated as safety issue: No ]
plasma C reactive protein (CRP) at anaesthesia induction, plasma C reactive protein (CRP) [ Time Frame: Day 2 and Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evolution of body temperature from before surgery to day 2 after surgery. [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
Time from the end of extra corporeal circulation to closure of the thorax, [ Time Frame: Closure of thorax ] [ Designated as safety issue: No ]
Amount of transfusions of erythrocytes, platelets, plasma. [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Visual analogical scale (VAS) for pain every 6 hours during stay in PACU, and every day afterwards to day 7, [ Time Frame: To day 7 ] [ Designated as safety issue: No ]
Amount of analgesic drugs, paracetamol and morphine. [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
EKG before surgery, 24 and 48 hours after surgery. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Plasma troponin I at induction of anaesthesia, 6, 24 and 48 hours after surgery. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Quality of cicatrisation of sternotomy immediately after surgery, at day 2 and 7 after surgery, on a 4 point scale. [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Clinical events: death, new surgery for haemostasis or infection within 2 weeks of surgery, and any event occurring within 30 days after surgery. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

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
1: Experimental Arnica 5CH and Bryonia 9CH (homeopathic drugs)	Drug: Arnica and Bryonia Arnica 5CH granules, 5 per day plus Bryonia 5CH Granules, 5 per day for 5 days
2: Placebo Comparator placebo Arnica 5CH and Bryonia 9CH	Drug: placebo 5 placebo granules for Arnica 5 CH and 5 placebo granules for Bryonia 5 CH

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774293

Locations

France
Anaesthesy service, Louis Pradel Hospital
Lyon, France, 69003

Sponsors and Collaborators

BOIRON

Hospices Civils de Lyon

Investigators

Principal Investigator:

Jean-Jacques Lehot, MD

Hospices Civils de Lyon, Lyon, France

More Information

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

Keywords provided by BOIRON:

Homoeopathic treatment,
heart surgery,
randomized clinical trial

ClinicalTrials.gov processed this record on January 16, 2009