Knee Osteoarthritis
Conditions
Brief summary
This study was a randomized, double-blind, placebo-controlled study evaluating the efficacy of an oral liquid HA supplement (A+HA) in symptoms relief and improvement of quality of life in knee osteoarthritis patients with mild knee pain.
Detailed description
Subjects were initially screened at the Randomization/Baseline Visit (Week 0). Eligible subjects were randomized at the same visit into the treatment period and received the assigned treatment in a double-blind fashion for 8 weeks. During the 8 weeks treatment period, there were three follow-up visits requested (Week 2, Week 4 and Week 8). Efficacy was measured by using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Short Form-36 (SF-36).
Interventions
DIETARY_SUPPLEMENTA+HA(tm)
oral solution of hyaluronic acid mixture in combination with glucosamine and chondroitin
DIETARY_SUPPLEMENTPlacebo
oral solution with no active ingredients
Sponsors
TOP Pharm & Medicalware
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female age \>= 40 years old * Diagnosed with knee OA which met the definition of Ahlbӓck classification12 and had knee joint symptoms within 30 days prior to enrollment
Exclusion criteria
* Had administered glucosamine one month prior to enrollment * Had known allergy to oral HA * BMI ≧40 kg/m2 * Knee OA was caused by occupational hazard or sports injury * Patients with known other causes of arthritis (infectious rheumatoid or psoriatic arthritis), bony or soft tissue malignancy or peripheral neuropathy involving the lower extremities, cardiopulmonary disease which limited walking more than knee pain, knee instability defined as a report of knee buckling or locking within the past month of the study knee, major neurological deficit that affected gait, psychiatric illness that limited informed consent or Parkinsonism * Women in pregnancy * Wheel chair users
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC | 8 weeks | Mean change from baseline to 8 weeks. The higher the score, the greater the severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 | 8 weeks | Mean change from baseline to 8 weeks. A higher score indicates a better QoL. |
Countries
Taiwan
Outcome results
None listed