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Homoeopathic Association in Aortic Valve Surgery

NCT00774293 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2008-10-17

No results posted yet for this study

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

Interventions

DRUG

placebo

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

DRUG

Arnica and Bryonia

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    collaborator OTHER

  • BOIRON

    lead INDUSTRY

Principal Investigators

  • Jean-Jacques Lehot, MD · Hospices Civils de Lyon, Lyon, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2007-06-30
Completion
2007-08-31

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00774293 on ClinicalTrials.gov