Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000484640
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy study of Faulding's sea cucumer extracts in osteoarthritis.
Scientific title
Randomised, double-blind, three armed, placebo controlled trial comparing the safety and efficacy of sea cucumber extract, sea cucumber extract with Boswellia extract and placebo in adults with osteoarthritis.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 606 0
Condition category
Condition code
Musculoskeletal 678 678 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cucumaria frondosa extract 1000mg or Cucumaria frondosa extract 1000mg plus 400mg Boswellia serrata extract over 11 weeks.
Intervention code [1] 543 0
None
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 820 0
Change in clinical symptoms of osteoarthritis as measured by the WOMAC osteoarthritis index after 11 weeks treatment
Timepoint [1] 820 0
After 11 weeks treatment
Secondary outcome [1] 1630 0
1) Change in clinical symptoms of osteoarthritis as measured by the Comprehensive Osteoarthritis Test (COAT).
Timepoint [1] 1630 0
After 11 weeks treatment.
Secondary outcome [2] 1631 0
2) Changes in platelet aggregation, euglobulin clot lysis times, lipid profiles and YKL-40.
Timepoint [2] 1631 0
After 11 weeks treatment.

Eligibility
Key inclusion criteria
1) Diagnosis of OA of the hip or knee. 2) Willing to discontinue all current OA treatment for the study duration commencing 4 weeks prior to baseline.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Severe false alignment of the knee or hip2) Surgery or arthroscopy of the knee or hip within 2 months of baseline3) Infectious or inflammatory rheumatic disease4) Reliance on the use of lipolytic, fibrinolytic, anti-coagulant or anti-inflammatory agents5) A history of trauma associated with the affected joints6) Any condition that in the opinion of the investigator 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 medications were supplied in numbered containers by the sponsor
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation scheme
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/06/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
129
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 750 0
Commercial sector/Industry
Name [1] 750 0
Faulding Healthcare Pty Ltd
Country [1] 750 0
Primary sponsor type
Commercial sector/Industry
Name
Faulding Healthcare Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 621 0
None
Name [1] 621 0
NA
Address [1] 621 0
Country [1] 621 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36242 0
Address 36242 0
Country 36242 0
Phone 36242 0
Fax 36242 0
Email 36242 0
Contact person for public queries
Name 9732 0
Dr Phillip Cheras
Address 9732 0
Mater Health Services
Level 2
Community Services Building
South Brisbane QLD 4101
Country 9732 0
Australia
Phone 9732 0
+61 7 38406120
Fax 9732 0
+61 7 38406119
Email 9732 0
p.cheras@uq.edu.au
Contact person for scientific queries
Name 660 0
Dr Phillip Cheras
Address 660 0
Mater Health Services
Level 2
Community Services Building
South Brisbane QLD 4101
Country 660 0
Australia
Phone 660 0
+61 7 38406120
Fax 660 0
+61 7 38406119
Email 660 0
p.cheras@uq.edu.au

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.