Homoeopathic Association in Aortic Valve Surgery

Aortic Valve Replacement Clinical Trial

— OMEO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774293
• Other study ID #: Boiron 041052
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2008
• Last updated: October 16, 2008
• Start date: September 2004
• Est. completion date: August 2007

Study information

• Verified date: October 2008
• Source: BOIRON
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Replacement

Intervention

Drug:
• placebo
5 placebo granules for Arnica 5 CH and 5 placebo granules for Bryonia 5 CH
• Arnica and Bryonia
Arnica 5CH granules, 5 per day plus Bryonia 5CH Granules, 5 per day for 5 days

Locations

Country	Name	City	State
France	Anaesthesy service, Louis Pradel Hospital	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
BOIRON	Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of drained liquid from the mediastinum or the pleura		At drain removal	No
Primary	plasma C reactive protein (CRP) at anaesthesia induction, plasma C reactive protein (CRP)		Day 2 and Day 7	No
Secondary	Evolution of body temperature from before surgery to day 2 after surgery.		Day 2	No
Secondary	Time from the end of extra corporeal circulation to closure of the thorax,		Closure of thorax	No
Secondary	Amount of transfusions of erythrocytes, platelets, plasma.		Day 7	No
Secondary	Visual analogical scale (VAS) for pain every 6 hours during stay in PACU, and every day afterwards to day 7,		To day 7	No
Secondary	Amount of analgesic drugs, paracetamol and morphine.		Day 7	No
Secondary	EKG before surgery, 24 and 48 hours after surgery.		48 hours	No
Secondary	Plasma troponin I at induction of anaesthesia, 6, 24 and 48 hours after surgery.		48 hours	No
Secondary	Quality of cicatrisation of sternotomy immediately after surgery, at day 2 and 7 after surgery, on a 4 point scale.		Day 7	No
Secondary	Clinical events: death, new surgery for haemostasis or infection within 2 weeks of surgery, and any event occurring within 30 days after surgery.		30 days	Yes