Effectiveness of Oral Hyaluronic Acid in Knee Osteoarthritis

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effectiveness of Oral Hyaluronic Acid (A+ HA(tm), TOP Pharm.) in Knee Osteoarthritis: Clinical Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Dietary Supplement: A+HA(tm)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A+HA(tm)<br>20 ml oral solution of hyaluronic acid mixture in combination with glucosamine and chondroitin in a bottle. Administration with 250 500 ml water under fasting condition in the morning. | Dietary Supplement: A+HA(tm)<br>* oral solution of hyaluronic acid mixture in combination with glucosamine and chondroitin<br>|
| Placebo Comparator: Placebo<br>20 ml oral solution without active ingredients in a bottle. Administration with 250 500 ml water under fasting condition in the morning. | Dietary Supplement: Placebo<br>* oral solution with no active ingredients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC | Mean change from baseline to 8 weeks. The higher the score, the greater the severity. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 | Mean change from baseline to 8 weeks. A higher score indicates a better QoL. | 8 weeks |