PainPhase 3NCT00222365
Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty
A Phase 3 study testing Arnica montana, 5 CH, Bryonia alba, 5 CH and Hypericum perforatum, 5 CH in people with Pain, run by University Hospital, Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain
- What is being tested?
- Arnica montana, 5 CH, Bryonia alba, 5 CH and Hypericum perforatum, 5 CH
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2003to May 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ranging from 18 to 60 years.
- Patients who are candidates for a ligamentoplasty of the anterior cruciate ligament.
Who cannot join
- Patients with corticoid and immunodepressor treatment
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Pain
- Being tested
- Arnica montana, 5 CH, Bryonia alba, 5 CH, Hypericum perforatum, 5 CH, Ruta graveolens, 3 DH
- Keywords
- homeopathy, assessment, pain, ligamentoplasty
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arnica montana, 5 CHDrug
Bryonia alba, 5 CHDrug
Hypericum perforatum, 5 CHDrug
Ruta graveolens, 3 DHDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption delivered by PCA between 0 and 24 hours after a knee ligamentoplasty
Secondary outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2003
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 165 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Investigators
- CRACOWSKI Jean-Luc, Dr, Principal investigator, Clinical Trial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222365
- Sponsor's protocol ID
- DCIC 03 10
- Status last verified
- Jul 2006
- First submitted
- 14 Sep 2005
- Last updated
- 14 Nov 2006
- Results posted
- No
Publications
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.
PubMed 9451677Ernst 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.
PubMed 12492603Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet. 1997 Sep 20;350(9081):834-43. doi: 10.1016/s0140-6736(97)02293-9.
PubMed 9310601Lokken P, Straumsheim PA, Tveiten D, Skjelbred P, Borchgrevink CF. Effect of homoeopathy on pain and other events after acute trauma: placebo controlled trial with bilateral oral surgery. BMJ. 1995 Jun 3;310(6992):1439-42. doi: 10.1136/bmj.310.6992.1439.
PubMed 7613277Cucherat M, Haugh MC, Gooch M, Boissel JP. Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group. Eur J Clin Pharmacol. 2000 Apr;56(1):27-33. doi: 10.1007/s002280050716.
PubMed 10853874
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty
- ClinicalTrials.gov ID
- NCT00222365
- Acronym / sponsor ID
- DCIC 03 10
- Conditions
- Pain
- Keywords
- homeopathy, assessment, pain, ligamentoplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 165 participants
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- May 2006
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age ranging from 18 to 60 years.
- Patients who are candidates for a ligamentoplasty of the anterior cruciate ligament.
Key exclusion criteria (1 listed)
- Patients with corticoid and immunodepressor treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arnica montana, 5 CH | Drug | – |
| Bryonia alba, 5 CH | Drug | – |
| Hypericum perforatum, 5 CH | Drug | – |
| Ruta graveolens, 3 DH | Drug | – |
Primary outcome
Morphine consumption delivered by PCA between 0 and 24 hours after a knee ligamentoplasty
2 secondary outcomes
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2006.
- Background: PubMed 9451677Barnes 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.
- Background: PubMed 12492603Ernst 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.
- Background: PubMed 9310601Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet. 1997 Sep 20;350(9081):834-43. doi: 10.1016/s0140-6736(97)02293-9.
- Background: PubMed 7613277Lokken P, Straumsheim PA, Tveiten D, Skjelbred P, Borchgrevink CF. Effect of homoeopathy on pain and other events after acute trauma: placebo controlled trial with bilateral oral surgery. BMJ. 1995 Jun 3;310(6992):1439-42. doi: 10.1136/bmj.310.6992.1439.
- Results publication: PubMed 10853874Cucherat M, Haugh MC, Gooch M, Boissel JP. Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group. Eur J Clin Pharmacol. 2000 Apr;56(1):27-33. doi: 10.1007/s002280050716.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CRACOWSKI Jean-Luc, Dr principal investigator
Clinical Trial Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arnica montana, 5 CH, Bryonia alba, 5 CH and Hypericum perforatum, 5 CH in people with Pain, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption delivered by PCA between 0 and 24 hours after a knee ligamentoplasty. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00222365, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2006.