Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000877088
Ethics application status
Approved
Date submitted
8/10/2010
Date registered
19/10/2010
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of 'arthritis relief plus' for osteoarthritis of the knee
Scientific title
A randomised placebo controlled trial of 4jointz for the symptoms of osteoarthritis of the knee
Secondary ID [1] 252842 0
This study has not been listed with any other registry.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 258356 0
Condition category
Condition code
Alternative and Complementary Medicine 258537 258537 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4JOINTZ is a novel combination of synergistic blend of standardised botanical extracts. It is topically applied and massaged directly into the joint(s). Approximately 3 grams or less than half a teaspoon is massaged into the knee joint 3 times a day for a period of 12 weeks.
Intervention code [1] 257361 0
Treatment: Other
Comparator / control treatment
Placebo product is made up of:
water - purified, aloe vera100% xanthan gum, cetyl alcohol, gycerl monosterate a/s, glycerol, methylparaben, dmdm hydantoin, dow corning 345, dow corning 200 350cts, olive oil, propyl paraben, propylene glycol, denatured ethanol, glycerol, caramel, choc brown ht, eucalyptus fragrance synthetic.

It is applied in exactly the same way as the active product. Approximately 3 grams or less than half a teaspoon is massaged into the knee joint 3 times a day for a period of 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 259374 0
Pain assessment - Pain(VAS) visual analogue scales
Timepoint [1] 259374 0
Baseline, week 4, week 8, week 12, week 16.
Primary outcome [2] 259448 0
KOOS (Knee injury and Osteoarthritis Outcome Score) knee survey.
Timepoint [2] 259448 0
Baseline, week 4, week 8, week 12, week 16.
Secondary outcome [1] 265892 0
Markers of inflammation
- Urine marker of cartilage breakdown (CTX-2)
Timepoint [1] 265892 0
Baseline, week 12
Secondary outcome [2] 266001 0
blood tests - interleukin 6 (iL6) and C reactive protein (CRP) inflammatory markers
Timepoint [2] 266001 0
Baseline, week 12

Eligibility
Key inclusion criteria
American Collegeof Rheumatology (ACR) criteria for knee osteoarthritis*
- Knee pain and at least 3 of 6
- Age > 50 years
- Stiffness < 30 minutes
- Crepitus
- Bony Tenderness
- Bony enlargement
- No palpable warmth

Pain visual analogue scale >40mm
Age >50
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Other forms of arthritis
- Xray showing Osteoarthritis Research Society International (OARSI) grade 3 joint space narrowing (JSN)
- Significant knee injury within last 6 months
- Inability to sign provide informed consent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257810 0
Commercial sector/Industry
Name [1] 257810 0
Arthritis Relief Plus Pty. Ltd.
Country [1] 257810 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Arthritis Relief Plus Pty. Ltd.
Address
PO Box 7687
GCMC
Queensland 9726
Country
Australia
Secondary sponsor category [1] 257015 0
None
Name [1] 257015 0
Address [1] 257015 0
Country [1] 257015 0
Other collaborator category [1] 251545 0
University
Name [1] 251545 0
Menzies Research Institute
Address [1] 251545 0
17 Liverpool St
Hobart
Tasmania 7000
Country [1] 251545 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259833 0
Tasmanian Health and Medical Human Research Ethics Comittee
Ethics committee address [1] 259833 0
University of Tasmania Office for Research Services
Private Bag 01
Hobart Tasmania 7001
Ethics committee country [1] 259833 0
Australia
Date submitted for ethics approval [1] 259833 0
04/12/2009
Approval date [1] 259833 0
26/04/2010
Ethics approval number [1] 259833 0
H10988

Summary
Brief summary
This study aims to determine the efficacy of arthritis relief plus for knee osteoarthritis pain. THis is a mix of 20 natural therapies. The design is randomised and double blind for 3 months followed by a one month wash out in 140 patients with significant knee pain due to arthritis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31750 0
Address 31750 0
Country 31750 0
Phone 31750 0
Fax 31750 0
Email 31750 0
Contact person for public queries
Name 14997 0
Graeme Jones
Address 14997 0
Menzies Research Institute
17 Liverpool Street
Hobart
Tasmania 7000
Country 14997 0
Australia
Phone 14997 0
+61 3 6226 7705
Fax 14997 0
+61 3 6226 7764
Email 14997 0
[email protected]
Contact person for scientific queries
Name 5925 0
Graeme Jones
Address 5925 0
Menzies Research Institute
17 Liverpool Street
Hobart
Tasmania 7000
Country 5925 0
Australia
Phone 5925 0
+61 3 6226 7705
Fax 5925 0
+61 3 6226 7764
Email 5925 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.