Homoeopathic Association in Aortic Valve Surgery

NCT00774293 | Completed Phase 4

• 1 other identifier: Boiron 041052
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Homoeopathic treatment,; heart surgery,; randomized clinical trial

Outcome Measures

Primary Outcomes (2)

• Amount of drained liquid from the mediastinum or the pleura

  At drain removal

• plasma C reactive protein (CRP) at anaesthesia induction, plasma C reactive protein (CRP)

  Day 2 and Day 7

Secondary Outcomes (9)

• Evolution of body temperature from before surgery to day 2 after surgery.

  Day 2

• Time from the end of extra corporeal circulation to closure of the thorax,

  Closure of thorax

• Amount of transfusions of erythrocytes, platelets, plasma.

  Day 7

• Visual analogical scale (VAS) for pain every 6 hours during stay in PACU, and every day afterwards to day 7,

  To day 7

• Amount of analgesic drugs, paracetamol and morphine.

  Day 7

Study Arms (2)

1

EXPERIMENTAL

Arnica 5CH and Bryonia 9CH (homeopathic drugs)

Drug: Arnica and Bryonia

2

PLACEBO COMPARATOR

placebo Arnica 5CH and Bryonia 9CH

Drug: placebo

Interventions

placebo DRUG

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

2

Arnica and Bryonia DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years, undergoing aortic valve surgery with extra corporeal circulation

You may not qualify if:

• 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.

Sponsors & Collaborators

• BOIRON: lead
• Hospices Civils de Lyon: collaborator

Study Sites (1)

Anaesthesy service, Louis Pradel Hospital

Lyon, 69003, France

Location

MeSH Terms

Interventions

Arnicae flos extract

Study Officials

• Jean-Jacques Lehot, MD

  Hospices Civils de Lyon, Lyon, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: September 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: August 1, 2007
• Last Updated: October 17, 2008

Record last verified: 2008-10

Locations

FR (1)