Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000664640
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
19/10/2005
Date last updated
19/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mechanisms of Action of an ATTORI Celery Seed Extract in Osteoarthritis
Scientific title
Mechanisms of Action of an ATTORI Celery Seed Extract in Osteoarthritis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 812 0
Condition category
Condition code
Musculoskeletal 876 876 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
400mg per day ATTORI Celery Seed extract versus placebo for 8 weeks
Intervention code [1] 465 0
Other interventions
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1123 0
To study actions of an ATTORI celery seed extract on laboratory markers including measures of coagualation
Timepoint [1] 1123 0
Baseline measures being taken at weeks -3 and 0 (first arm) and weeks 13 and 16 (second arm) and treatment measures taken at weeks 3 and 6 (first arm) and weeks 19 and 22 (second arm).
Primary outcome [2] 1124 0
To study actions of an ATTORI celery seed extract on laboratory markers including measures of fibrinolysis
Timepoint [2] 1124 0
Baseline measures being taken at weeks -3 and 0 (first arm) and weeks 13 and 16 (second arm) and treatment measures taken at weeks 3 and 6 (first arm) and weeks 19 and 22 (second arm).
Primary outcome [3] 1125 0
To study actions of an ATTORI celery seed extract on laboratory markers including measures of lipids
Timepoint [3] 1125 0
Baseline measures being taken at weeks -3 and 0 (first arm) and weeks 13 and 16 (second arm) and treatment measures taken at weeks 3 and 6 (first arm) and weeks 19 and 22 (second arm).
Primary outcome [4] 1126 0
To study actions of an ATTORI celery seed extract on laboratory markers including measures of inflammation
Timepoint [4] 1126 0
Baseline measures being taken at weeks -3 and 0 (first arm) and weeks 13 and 16 (second arm) and treatment measures taken at weeks 3 and 6 (first arm) and weeks 19 and 22 (second arm).
Primary outcome [5] 1127 0
To study actions of an ATTORI celery seed extract on laboratory markers including measures of cartilage
Timepoint [5] 1127 0
Baseline measures being taken at weeks -3 and 0 (first arm) and weeks 13 and 16 (second arm) and treatment measures taken at weeks 3 and 6 (first arm) and weeks 19 and 22 (second arm).
Primary outcome [6] 1128 0
To study actions of an ATTORI celery seed extract on laboratory markers including measures of bone degradation
Timepoint [6] 1128 0
Baseline measures being taken at weeks -3 and 0 (first arm) and weeks 13 and 16 (second arm) and treatment measures taken at weeks 3 and 6 (first arm) and weeks 19 and 22 (second arm).
Secondary outcome [1] 2081 0
To determine the efficacy of an ATTORI Celery Seed Extract for the treatment of Osteoarthritis by performing a randomised clinical trial utilising the Western Ontario and McMasters Universities (WOMAC) OA index for hip and knee OA, a well validated instrument.
Timepoint [1] 2081 0
Baseline measures being taken at weeks -3 and 0 (first arm) and weeks 13 and 16 (second arm) and treatment measures taken at weeks 3 and 6 (first arm) and weeks 19 and 22 (second arm).
Secondary outcome [2] 2082 0
A Quality of Life questionairre (SF36) will also be included in this assessment.
Timepoint [2] 2082 0
Baseline measures being taken at weeks -3 and 0 (first arm) and weeks 13 and 16 (second arm) and treatment measures taken at weeks 3 and 6 (first arm) and weeks 19 and 22 (second arm).

Eligibility
Key inclusion criteria
Diagnosis of painful OA of the hip or knee, with or without other joint involvement, 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: osteophytes, osteosclerosis, cysts or joint space narrowing, and(iii) a WOMAC score not less than 20.Subjects who have given their informed written consent to participate.Subjects willing to discontinue their current OA treatment for the study duration, commencing at least 2 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 of childbearing age who agree to continue using contraceptive measures for the duration of the study.
Minimum age
18 Years
Maximum age
75 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 on 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 in the previous 2 months.Participation in another therapeutic trial within the previous 30 days.Infectious or inflammatory diseases.Female subjects who are pregnant or lactating.Subjects who are unwilling to comply with the study requirements including discontinuation of current osteoarthritis treatment.Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.Subjects with contra-indications to the study medication or to paracetamol.Reliance on the use of lipolytic, fibrinolytic, anti-coagulant or anti-inflammatory agents or agents that influence platelet function (especially aspirin, aspirin containing compounds and other NSAIDs).A history of trauma associated with the affected joints.Subjects with insulin dependent diabetes mellitus.Subjects with known hypersensitivity to celery.Subjects with any bleeding disorder.Subjects with a history of alcohol or substance abuseSubjects with significant gastrointestinal or renal disease.

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 and database had been locked
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation schedule was provided by Quintiles (study moniters)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/06/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 965 0
Commercial sector/Industry
Name [1] 965 0
The Australian Tea Tree Oil Research Institute Ltd
Country [1] 965 0
Australia
Primary sponsor type
University
Name
ATTORI
Address
Country
Secondary sponsor category [1] 834 0
None
Name [1] 834 0
NA
Address [1] 834 0
Country [1] 834 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2263 0
Greenslopes Private Hospital
Ethics committee address [1] 2263 0
Ethics committee country [1] 2263 0
Australia
Date submitted for ethics approval [1] 2263 0
Approval date [1] 2263 0
Ethics approval number [1] 2263 0
Ethics committee name [2] 2264 0
Southern Cross University
Ethics committee address [2] 2264 0
Ethics committee country [2] 2264 0
Australia
Date submitted for ethics approval [2] 2264 0
Approval date [2] 2264 0
Ethics approval number [2] 2264 0

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

Contacts
Principal investigator
Name 35615 0
Address 35615 0
Country 35615 0
Phone 35615 0
Fax 35615 0
Email 35615 0
Contact person for public queries
Name 9654 0
Dr Phillip Cheras
Address 9654 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
Mater Health Services
2nd Floor
Community Services Buildings
39 Annerley Rd
South Brisbane QLD 4101
Country 9654 0
Australia
Phone 9654 0
+61 7 38406120
Fax 9654 0
Email 9654 0
[email protected]
Contact person for scientific queries
Name 582 0
Dr Phillip Cheras
Address 582 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
Mater Health Services
2nd Floor
Community Services Buildings
39 Annerley Rd
South Brisbane QLD 4101
Country 582 0
Australia
Phone 582 0
+61 7 38406120
Fax 582 0
Email 582 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.