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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00774293
Other study ID # Boiron 041052
Secondary ID
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


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
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