Table 2.
Inclusion and exclusion criteria
| Inclusion Criteria |
|---|
| Males and females 40-75 years old |
| Females of childbearing potential must agree to use a medically approved form of birth control and have a negative urine pregnancy test result |
| Unilateral or bilateral OA of the knee for greater than 3 months (American College of Rheumatology criteria) confirmed by radiologist's report, i.e. X-rays showing osteophytes, joint space narrowing or subchondral bone sclerosis (eburnation) |
| Erythrocyte sedimentation rate (ESR) < 40 mm/hr |
| Moderate OA as indicated by Lequesne's functional index score of 4.5-7.5 after 7 day withdrawal of usual medications |
| Able to walk |
| Availability for duration of study period (3-4 months) |
| Subject using other therapies for OA, such as exercise, heat/cold therapy, joint protection and physiotherapy/occupational therapy agrees to continue these therapies as normal avoiding changes in frequency or intensity and to record therapies in the study diary |
| Subject agrees not to start any new therapies for OA during the course of the study |
| Able to give informed consent |
| Exclusion Criteria |
| History of underlying inflammatory arthropathy; septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia; Wilson's disease; ochronosis; haemochromatosis; heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis |
| History of asthma, history of diabetes (Type I or Type II) |
| Hyperuricemia (urate, males > 480 umol/L, females > 450 umol/L) |
| Expectation of surgery in the next 4 months |
| Recent injury in the area affected by OA of the knee, i.e. meniscal tear (past 4 months) |
| Cartilage reconstruction procedure in the target knee |
| Severe OA as indicated by Lequesne's functional index score of 8 or greater, after 7 day withdrawal of usual medications |
| Intra-articular corticosteroid injections in the target knee within the last 3 months |
| Viscous injections in the target knee within the last 6 months |
| Hypersensitivity to NSAIDs |
| Abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of normal; elevated creatinine, males > 125 umol/L, females > 110 umol/L) |
| Abnormal findings on complete blood count |
| History of coagulopathies, history of peptic ulceration and upper GI hemorrhage |
| Uncontrolled hypertension |
| History of congestive heart failure, history of allergic reaction to chicken and/or eggs |
| History of allergic reaction to local anesthetic or to any ingredients in the test product including shellfish |
| Hyperkalemia (potassium > 6.2 mmol/L) |
| Anticipated problems with product consumption |
| History of cancer as well as gastrointestinal, renal, hepatic, cardiovascular, hematological, or neurological disorders |
| High alcohol intake (>2 standard drinks per day) |
| Pregnant, breastfeeding or planning to become pregnant during the study |
| History of psychiatric disorder that may impair the ability of subjects to provide written informed consent |
| Use of other natural health products, including glucosamine and chondroitin, one month prior to study and during the study, other than multivitamin and mineral supplements containing vitamins and minerals as the sole medicinal ingredients |
| Use of concomitant prohibited medication (narcotics, oral NSAIDs, topical NSAIDs) within four weeks of randomization |
| Use of acetaminophen or ibuprofen within 7 days of randomization |
| Subject is unwilling to stop taking pain medication other than the study medication (for arthritis or other types of pain) or is unwilling to stop taking other medications for the treatment of OA |
| Any other condition that, in the opinion of the investigator, would adversely affect the subject's ability to complete the study or its measures |