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Trial registered on ANZCTR


Registration number
ACTRN12608000468325
Ethics application status
Approved
Date submitted
19/03/2008
Date registered
17/09/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Efficacy of a Chinese Herbal Medicine in the Treatment of Osteoarthritis of the Knee
Scientific title
An evaluation of efficacy of treatment of osteoarthritis of the knee with Chinese herbal medicine will be conducted in a placebo-controlled, oral-administration randomised clinical trial, and assessed by the Western Ontario and Mc Masters Universities (WOMAC) oseoarthritis index score.
Secondary ID [1] 252377 0
Evaluation of CHM treatment of knee OA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis of the knee 2943 0
Condition category
Condition code
Musculoskeletal 3082 3082 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chinese herbal medicine Bai Niu Capsule(composed of 6 commonly used Chinese herbs) taken orally over 12 weeks in capsule form; 5 capsules three times per day. Details of the Bai Niu Capsule are commercial-in- confidence.
Intervention code [1] 2676 0
Treatment: Drugs
Comparator / control treatment
Matched placebo (lactose) in capsule form taken orally, 5 capsules three times per day for 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 3968 0
Western Ontario and McMasters Universities (WOMAC) osteoarthitis index score
Timepoint [1] 3968 0
Baseline, 12 weeks
Secondary outcome [1] 6668 0
Short Form 36 (SF36) Version 2
Timepoint [1] 6668 0
Baseline, 12 weeks
Secondary outcome [2] 6669 0
Physicians Global Assessment which is a global assessment of patient functioning made by the physician.
Timepoint [2] 6669 0
Baseline, 12 weeks
Secondary outcome [3] 6670 0
Patient Global Assessment which is a self-assessment of level of functioning made by the patient
Timepoint [3] 6670 0
Baseline, 12 weeks

Eligibility
Key inclusion criteria
1. Unilateral or bilateral osteoarthritis (OA) of the knee and fulfil the criteria provided the American College of Rheumatology (ACR) 1995 (ACR) will be eligible to participate. The ACR criteria are: knee pain and radiographic osteophytes and at least one of the following three items:

a. age > 50 years;
b. morning stiffness = 30 minutes in duration;
c. crepitus on motion.

2. Radiographic evidence of OA will be based on the Kellgren-Lawrence radiographic system (either grade II or grade III severity primary tibio-femoral OA as a condition of inclusion).

3. Fluent in the English language or able to give informed consent and complete study assessments with the assistance of an interpreter.

4. Provide written informed consent to participate in the study and be willing to comply with the study procedures.

5. No abnormal finding of clinical relevance at the screening evaluation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Accompanying osteoarthritis (OA) of hip of sufficient severity to interfere with the functional assessment of the knee.

2. Secondary OA or rheumatoid inflammatory or any other type of arthritis.

3. Previous and ongoing treatment with oral symptomatic slow acting drugs in OA (SYSADOA) treatment within 2 months before the study (e.g. glucosamine sulphate, chondroitin sulphate, diacerein, piascledine).

4. Requiring arthroplasty within 2 months or anticipating any need for a surgical procedure on the involved joint during the study.

5. Have received intra-articular treatment of the involved joint or joint lavage in the previous 6 months (e.g., corticosteroids or hyaluronic acid).

6. Knee surgery during the previous 3 months.

7. Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs).

8. Taking any regular prescribed medicine for OA during the trial except for medications pain that are taken ‘as required’ for break-through pain.

9. Any significant systemic illnesses or medical conditions that could lead to difficulty complying with the protocol;

10. Screening or baseline liver function tests Serum Glutamic Oxaloacetic Transaminase (SGOT), Aspartate Aminotransferase (AST) and/or Serum Glutamic Pyruvic Transaminase (SGPT), Alanine Aminotransferase (ALT) >2.5 times the upper limits of laboratory reference range.

11. Any additional condition(s) that, in the investigator’s opinion, would prohibit the subject from completing the study, or not be in the best interest of the subject.

12. Pregnancy or active breast-feeding. Female subjects of childbearing potential (not postmenopausal for at least 1year or surgically sterilized) must agree not to become pregnant during the duration of the study. Specifically, they must agree to use an appropriate contraceptive regimen.

13. Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel, electrolytes including sodium (Na+) and potassium (K+), and urinalysis).

14. Evidence of clinically relevant, cardiovascular, haematological, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic or psychiatric disorder.

15. Use of any over the counter product medications, herbal products, diet aids, hormone supplements, etc., within 14 days prior to dosing unless approved by both the Principal Investigator.

16. Use of any medication outlined in section 9.2.

17. Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to inclusion.

18. Unwilling or unable to provide written 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)
Allocation concealment via central randomisation (computer)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomised number code will be used to label study medication bottles. Participants allocated medication in sequence of enrolment into study.
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
Recruiting
Date of first participant enrolment
Anticipated
1/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 793 0
3000

Funding & Sponsors
Funding source category [1] 3197 0
University
Name [1] 3197 0
Victoria University
Country [1] 3197 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Victoria University
McKechnie St
St Albans Victoria 3021
Country
Australia
Secondary sponsor category [1] 2868 0
Commercial sector/Industry
Name [1] 2868 0
Nucleus Network
Address [1] 2868 0
Burnett Building
89 Commercial Rd
Prahran Victoria 3181
Country [1] 2868 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5180 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 5180 0
Ethics committee country [1] 5180 0
Australia
Date submitted for ethics approval [1] 5180 0
25/03/2008
Approval date [1] 5180 0
Ethics approval number [1] 5180 0
98 / 08
Ethics committee name [2] 5734 0
The Victoria University Human Research Ethics Committee
Ethics committee address [2] 5734 0
Office for Research
Footscray Park Campus
Victoria University
Ethics committee country [2] 5734 0
Australia
Date submitted for ethics approval [2] 5734 0
Approval date [2] 5734 0
10/07/2008
Ethics approval number [2] 5734 0

Summary
Brief summary
The aim of the study is to investigate the efficacy of a Chinese herbal medicine in treating symptoms of osteoarthritis of the knee. The study hypothesis is that the Chinese herbal medicine will be effective in treatment of symptoms and signs associated with osteoarthitis of the knee.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28450 0
Address 28450 0
Country 28450 0
Phone 28450 0
Fax 28450 0
Email 28450 0
Contact person for public queries
Name 11607 0
Dr Kylie O'Brien
Address 11607 0
Faculty of Health, Engineering and Science
Victoria University
St Albans Campus
McKechnie St
St Albans Victoria 3021
Country 11607 0
Australia
Phone 11607 0
+61 3 99192792
Fax 11607 0
Email 11607 0
[email protected]
Contact person for scientific queries
Name 2535 0
Dr Kylie O'Brien
Address 2535 0
Faculty of Health, Engineering and Science
Victoria University
St Albans Campus
McKechnie St
St Albans Victoria 3021
Country 2535 0
Australia
Phone 2535 0
+61 3 99192792
Fax 2535 0
Email 2535 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

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