Musculoskeletal Diseases osteoarthritis
Conditions
Interventions
IPG group
Glucosamine+Chondrointin (GC)
Sponsors
gateway Health Alliance
Laboratory of Nutrition and Nutritional Biochemistry
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ¿ Ambulatory, 40¿75 years of age, with a BMI of 18 to 30 kg/m2 ¿ Females of childbearing age must agree to use a medically approved form of birth control and have a negative urine pregnancy test result throughout the study ¿ Female subjects of limited to no childbearing potential must be amenorrheic for at least 1 year or have had a hysterectomy, a bilateral oophorectomy, or both ¿ Unilateral or bilateral OA of the knee for greater than 3 months plus a Kellgren and Lawrence radiographic grade of 2 or 3 ¿ VAS score during knee movement between 40¿70 mm after 7 day withdrawal of excluded medications ¿ LFI score between 6¿10 points after 7 day withdrawal of excluded medications ¿ Clinical laboratory results that are within normal range or considered not clinically significant by the Principal Investigator ¿ Be willing to participate in all scheduled visits, tests, and other trial procedures according to the clinical protocol ¿ Be willing to refrain from taking ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC or prescription) during the entire trial other than acetaminophen (paracetamol) as rescue medication ¿ Provide a signed and dated informed consent indicating that the subject has been informed of all pertinent aspects and possible risks associated with participation in the trial
Exclusion criteria
Exclusion criteria: ¿ History of hypersensitivity to the rescue medication or any of the products used in the study ¿ History of hypersensitivity to eggs, chicken or fowl, or shellfish ¿ History of inflammatory arthropathy, severe RA, OA (VAS score greater than 70), or Systemic Lupus Erythematosus ¿ Hyperuricemia (>440 ¿mol/L), past history of gout, or both ¿ Anticipation of surgery within the next 4 months ¿ Recent injury in the target knee (past 4 months) ¿ History of use for corticosteroid, indomethacin, glucosamine & chondroitin within 3 months of Visit 2; intra-articular treatments, including injections of corticosteroid or hyaluronic acid; consumption of Omega 3 fatty acids dietary supplements within 6 months preceding the treatment period (a 2-week washout period is allowed for subjects taking omega 3 fatty acid supplements) ¿ History of congestive heart failure ¿ Anticipated problems with product consumption ¿ Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies within the last 5 years ¿ High alcohol intake (>2 standard drinks per day) or use of recreational drugs (e.g., cocaine, methamphetamine, marijuana, etc.) ¿ Females who are pregnant or lactating or planning to become pregnant ¿ History of any mental illness that might impair the ability of subjects to provide a written informed consent ¿ Consumed acetaminophen (paracetamol), ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC or prescription), or any natural health product, (excluding vitamins) within 7 days of first visit ¿ Participation in any clinical trials within 30 days prior to first visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was defined as the change in total WOMAC score from the baseline through Day 180 for the IPG® group versus the placebo (GC group). ;Change from baseline through day 180 versus GC for all endpoints including the following scores: (1) mean VAS; (3) LFI; and (4) knee flexion | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary endpoints included the change in serum biomarker, C-reactive protein (CRP) plus synovial fluid biomarkers interleukin (IL)-6, and matrix metalloproteinase (MMP)-3 | — |
Countries
Cameroon
Contacts
Public ContactHarinder Singh
Harinder Medicare
Outcome results
None listed