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Homoeopathic Association in Aortic Valve Surgery

NCT ID: NCT00774293

Last Updated: 2008-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Valve Replacement

Keywords

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Homoeopathic treatment, heart surgery, randomized clinical trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Arnica 5CH and Bryonia 9CH (homeopathic drugs)

Group Type EXPERIMENTAL

Arnica and Bryonia

Intervention Type DRUG

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

2

placebo Arnica 5CH and Bryonia 9CH

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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placebo

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

Intervention Type DRUG

Arnica and Bryonia

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role collaborator

BOIRON

INDUSTRY

Sponsor Role lead

Responsible Party

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Boiron

Principal Investigators

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Jean-Jacques Lehot, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon, Lyon, France

Locations

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Anaesthesy service, Louis Pradel Hospital

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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Boiron 041052

Identifier Type: -

Identifier Source: org_study_id