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.

Victoria University0 sites60 target enrollmentSeptember 17, 2008

Overview

No summary available.

Registry

who.int

Start Date

September 17, 2008

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•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.

•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.