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Trial registered on ANZCTR


Registration number
ACTRN12605000630617
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
12/10/2005
Date last updated
12/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of anti-coagultion, lipolytic and anti-inflammatory phytotherapeutic agents for the treatment of osteoarthritis
Scientific title
Efficacy of anti-coagultion, lipolytic and anti-inflammatory phytotherapeutic agents for the treatment of osteoarthritis
Universal Trial Number (UTN)
Trial acronym
BR95628
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 758 0
Condition category
Condition code
Musculoskeletal 834 834 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active (400mg Garlic, 40mg Ginkgo and 250mg Devils Claw) one tablet three time daily, for 12 weeks.
Intervention code [1] 549 0
Other interventions
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1071 0
Change in WOMAC score from baseline to 12 weeks of treatment.
Timepoint [1] 1071 0
At baseline and after 12 weeks of treatment.
Secondary outcome [1] 1986 0
The change in laboratory lipid status.
Timepoint [1] 1986 0
From baseline to endpoint (12 weeks of treatment).
Secondary outcome [2] 1987 0
The change in laboratory coagulation status.
Timepoint [2] 1987 0
From baseline to endpoint (12 weeks of treatment).

Eligibility
Key inclusion criteria
Subjects with a diagnosis of painful OA of the hip or knee, with or without other joint involvment, as defined by:i) hip or knee pain while standing, walking and/or in motion of at least 3 months duration, and ii) evidence of one or more of the following features in an X-ray picture taken in the past 6 months: osteophytes, cysts or joint space narrowingSubjects with profiles defined by (Triglycerides > 1mmol/L and (ECLT (euglobulin clot lysis time) >190min or Cholesterol >5.9mmol/L)) or (Diastolic blood pressure >85mmHg and <110mmHg).Subjects willing to discontinue their current OA treatment for the study duration, commencing 2 weeks pripor to their first visit (29 weeks).
Minimum age
40 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of joint replacementSurgery on the knee or hip within the past 12 months or arthroscopy within the past 6 months.Adminstration of any long-acting osteoarthritis therapy in the previous 3 months.Subjects will contra-indications to the study medication or to paracetamol (inlcuding allergies)Subjects with a Diastolic blood pressure of >=100mmHg or systolic blood pressure >= 180mmHg at any stage of the studySubjects on any medication known to interact with anti-hypertensive or lipid lowering drugs or to influence platelet function.

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)
Sealed envelopes were held until all subjects had completed the studyand database had been locked. Placebo and active had a similar appearance and weight with the tablets being enterically coated. The placebo tablet were stored in jars that contain dessicant packets that had been laced with garlic oil.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule was provided by the sponsor Blackmores with no restriction method employed
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 922 0
Commercial sector/Industry
Name [1] 922 0
Blackmores Ltd
Address [1] 922 0
Country [1] 922 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Blackmores Ltd
Address
Country
Australia
Secondary sponsor category [1] 780 0
None
Name [1] 780 0
Na
Address [1] 780 0
Country [1] 780 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2210 0
Greenslopes Private Hospital
Ethics committee address [1] 2210 0
Ethics committee country [1] 2210 0
Australia
Date submitted for ethics approval [1] 2210 0
Approval date [1] 2210 0
Ethics approval number [1] 2210 0

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

Contacts
Principal investigator
Name 36084 0
Address 36084 0
Country 36084 0
Phone 36084 0
Fax 36084 0
Email 36084 0
Contact person for public queries
Name 9738 0
Dr Phillip Cheras
Address 9738 0
Australian Centre for Complementary Medicine Education and Research
Mater Health Services
2nd Floor
Community Services Building
39 Annerley Rd
South Brisbane QLD 4101
Country 9738 0
Australia
Phone 9738 0
+61 7 38406120
Fax 9738 0
Email 9738 0
p.cheras@uq.edu.au
Contact person for scientific queries
Name 666 0
Dr Phillip Cheras
Address 666 0
Australian Centre for Complementary Medicine Education and Research
Mater Health Services
2nd Floor
Community Services Building
39 Annerley Rd
South Brisbane QLD 4101
Country 666 0
Australia
Phone 666 0
+61 7 38406120
Fax 666 0
Email 666 0
p.cheras@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary