Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000256673
Ethics application status
Approved
Date submitted
25/08/2005
Date registered
1/09/2005
Date last updated
21/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Individualised and Complex Homeopathic Treatment in Osteoarthritis using a Novel Research design
Scientific title
A randomised phase III study to evaluate the effects of individualised and complex homeopathy in the treatment of osteoarthritis to improve pain, stiffness and physical function
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 343 0
Condition category
Condition code
Musculoskeletal 396 396 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Homeopathic simplex
This preparation is individually prescribed after homeopathic interview. This could be any of the homeopathic medications (200C potency) manufactured by Brauer Natural Medicine.
Sublingual administration on Day 1 of the 4-week treatment period.

2. Homeopathic complex
The composition of the complex is a mixture comprising Actaea spicata 3X (Baneberry), Causticum 12X (Hydrated Lime), Rhus toxicodendron 12X (Poison oak), Kalmia latifolia 5C (Mountain laurel), Bryonia 6C (Wild Hops), Colocynthis 6C (Bitter Cucumber), Dulcamara 6C (Deadly Nightshade), Ruta Graveolens 6C (Rue), Kali Carbonicum 6C (Potassium carbonate), Cimicifuga racemosa 9C (Black Cohosh).
Administration is 2 pumps sublinguallly tds for the 4-week treatment period.
Intervention code [1] 260 0
Treatment: Other
Comparator / control treatment
Placebo
The placebo matching the active individualized homeopathic preparations will be administered as a dry pilule and is composed of sucrose.
The placebo matching the homeopathic complex will be administered as per the oral spray and is composed of a water and alcohol solution.
Control group
Placebo

Outcomes
Primary outcome [1] 457 0
The Western Ontario and McMasters Universities (WOMAC) OA index for hip and knee OA, a well validated instrument. Validation studies have shown that shifts of around 20% in any of the WOMAC subscales of pain, stiffness and physical function are clinically significant.
Timepoint [1] 457 0
Measured at week -4 (screening); week 0 (baseline) and week +4 (post-treatment)
Secondary outcome [1] 989 0
1. Comprehensive Osteoarthritis Test
Timepoint [1] 989 0
Measured daily during washout and treatment phases.
Secondary outcome [2] 990 0
2. Short Form-12 (SF-12)
Timepoint [2] 990 0
Measured pre and post-treatment.
Secondary outcome [3] 991 0
3. Paracetamol usage
Timepoint [3] 991 0
Measured daily during washout and treatment phases.

Eligibility
Key inclusion criteria
Subjects with a diagnosis of osteoarthritis (OA) of the hip or knee, with or without other joint involvement, as defined by:-hip/knee pain while standing, walking and/or in motion of at least 3 months duration, and-evidence of one or more of the following features in an X-ray picture: osteophytes, osteosclerosis, cysts, or joint space narrowing, and-a total WOMAC score of 30 or more at study commencement.Subjects willing to discontinue their current OA treatment for the duration of the study, commencing at least 4 weeks prior to their first visit. This includes treatment with intra-articular injections, corticosteroids, NSAIDs, non-prescription therapies, chondroprotective agents, occlusive dressings, physiotherapy, or orthopaedic technical measures.Subjects who have given their written informed consent.Female subjects of childbearing age who agree to continue using contraceptive measures for the duration of the study.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe false alignment of the axis of the knee or hip.Surgery of the knee or hip within the past 2 months or arthroscopy within the past 2 months.Administration of intra-articular injections (e.g. corticosteroids, chondroprotective agents) or treatment with any long acting osteoarthritic therapy within one month of the study commencement.Subjects who use lipolytic, fibrinolytic, anti-coagulent or anti-inflammatory agents or agents that influence platelet function (especially aspirin, aspirin-containing compounds and other NSAIDs) or complementary natural antiarthrotic agents. Infectious, inflammatory rheumatic diseases (e.g. Ross River Fever, rheumatoid arthritis).Female subjects who are pregnant or lactating.Subjects who are unwilling to comply with the study.Subjects with contra-indications to the study medication.Subjects with any condition that, in the opinion of the investigators, might interfere with the evaluation of the study objective.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study interventions were supplied in sealed numbered containers and dispensed by an independent dispenser.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation code was generated in blocks using SPSS software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
135
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 448 0
Commercial sector/Industry
Name [1] 448 0
Brauer Natural Medicine
Country [1] 448 0
Australia
Primary sponsor type
University
Name
Australian Centre for Complementary Medicine Education and Research
Address
Country
Australia
Secondary sponsor category [1] 365 0
None
Name [1] 365 0
Nil
Address [1] 365 0
Country [1] 365 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1421 0
Southern Cross University
Ethics committee address [1] 1421 0
Ethics committee country [1] 1421 0
Australia
Date submitted for ethics approval [1] 1421 0
Approval date [1] 1421 0
Ethics approval number [1] 1421 0
Ethics committee name [2] 1422 0
The Queensland University
Ethics committee address [2] 1422 0
Ethics committee country [2] 1422 0
Australia
Date submitted for ethics approval [2] 1422 0
Approval date [2] 1422 0
Ethics approval number [2] 1422 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35564 0
Address 35564 0
Country 35564 0
Phone 35564 0
Fax 35564 0
Email 35564 0
Contact person for public queries
Name 9449 0
Don Baker
Address 9449 0
Rifle Range Rd
Lismore NSW 2480
Country 9449 0
Australia
Phone 9449 0
+61 2 66269288
Fax 9449 0
+61 2 66203307
Email 9449 0
[email protected]
Contact person for scientific queries
Name 377 0
Professor Steven Myers
Address 377 0
Rifle Range Rd
Lismore NSW 2480
Country 377 0
Australia
Phone 377 0
+61 2 66203403
Fax 377 0
+61 2 66203307
Email 377 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.