Homeopathy Assessment in Terms of the Consumption of Anal... | NCT00222365

Studies
Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty

NCT00222365

Sponsor

University Hospital, Grenoble

Status

Terminated

Last Update Posted

Nov 14, 2006Estimated

Enrollment

165

Phase

Phase 3

Conditions

Pain

Interventions

Arnica montana, 5 CH
Bryonia alba, 5 CH
Hypericum perforatum, 5 CH
Ruta graveolens, 3 DH

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Not provided

Completion Date

May 2006

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2006

Last Update Posted Date

Nov 14, 2006Estimated

Description Module

Brief Summary

This is an add-on, double blind, and randomised clinical trial with three groups: a homeopathic group, a placebo group, and a temporal control group.

The aim of this trial is to assess the effect of homeopathy on the consumption of morphine delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.

Detailed Description

We test the effectiveness of an homeopathic drug versus placebo and a temporal control group (patient with no add-on treatment) following orthopedic knee surgery.

All patients have a PCA of morphine for 24 hours after surgery. After this period they can take an oral tablet of morphine on request.

Group A: Patients with study treatment (homeopathy) allocation. Double blind group with 70 patients

Group B: Patients with placebo allocation. Double blind group with 70 patients

Group C: Temporal control group with patients who take only the morphine. Open group with 25 patients

The total power: 70 +70 + 25 = 165 patients

Main Objective:

To assess the effect of homeopathy in terms of morphine consumption delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.

Secondary Objectives:

To assess the effect of homeopathy in terms of total morphine consumption between H24 and H72 after a knee ligamentoplasty.
To assess the effect of homeopathy on the pain perception using a analogical visual scale for 72 hours.
To asses the placebo effect of the homeopathic treatment.

Main Assessment Criterion:

Morphine consumption delivered by PCA between 0 and 24 hours after knee ligamentoplasty

Secondary Assessment Criteria:

Morphine consumption between 0 and 72 hours after ligamentoplasty
Pain assessment at H0, H4, H24 and H72 using 10 cm Analogical Visual Scale

Inclusion Criteria:

age ranging from 18 to 60.
patients candidates for a ligamentoplasty of the anterior cruciate ligament.

Exclusion Criteria:

patient with corticoid and immunodepressor treatment

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

165

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arnica montana, 5 CH	Drug
Bryonia alba, 5 CH	Drug
Hypericum perforatum, 5 CH	Drug
Ruta graveolens, 3 DH	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morphine consumption delivered by PCA between 0 and 24 hours after a knee ligamentoplasty

Secondary Outcomes

Measure	Description	Time Frame
Morphine consumption between 0 and 72 hours after the ligamentoplasty
Pain assessment at hour 0 (H0), H4, H24 and H72 with 10 cm Analogical Visual Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ranging from 18 to 60 years.
Patients who are candidates for a ligamentoplasty of the anterior cruciate ligament.

Exclusion Criteria:

Patients with corticoid and immunodepressor treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
CRACOWSKI Jean-Luc, Dr	Clinical Trial Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Grenoble		Grenoble		38043	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9451677	Background	Barnes J, Resch KL, Ernst E. Homeopathy for postoperative ileus? A meta-analysis. J Clin Gastroenterol. 1997 Dec;25(4):628-33. doi: 10.1097/00004836-199712000-00016.
12492603	Background	Ernst E. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol. 2002 Dec;54(6):577-82. doi: 10.1046/j.1365-2125.2002.01699.x.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C000712347	Arnicae flos extract
C422326	Hypericum extract LI 160