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

Study Overview
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Brief Summary
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This is a double-blinded, placebo-controlled, randomized trial to assess the efficacy of oral solution of hyaluronic acid mixture (A+ HA(tm)). During 8 weeks treatment period, there were three follow-up visits requested (Week 2, Week 4 and Week 8).

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 treatment period, and received the assigned treatment in a double-blind fashion for 8 weeks. Efficacy was measured by the several questionnaire including Knee injury and Osteoarthritis (KOOS), the Short Form-36 (SF-36) and Pittsburgh Sleep Quality Index (CPSQI) for each visit. Incidences of adverse events (AEs) were monitored for each subject once the subject had received 1 dose of study medication; the incidence of serious AEs (SAEs) were monitored for each subject once the subject had signed the informed consent through to the End-of-Study or ET Visit. Vital signs were measured at baseline and End-of-Study or ET Visit.

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: Age >= 40 years old Male or Female With osteoarthritis of the knee based on the definition of Ahlback 1968 and with significant symptoms within 30 days before enrollment. No limitation for use of concomitant medication Exclusion Criteria: Use of Glucosamine within 1 month before enrollment Osteoarthritis of the knee due to exercise or occupational injury Allergy with Oral Hyaluronic Acid Bilateral Total Knee Replacement Pregnant Need use wheelchairs BMI≥40 With at least one condition: Known other causes of arthritis (infectious arthritis, rheumatoid arthritis, connective tissue disease, gout, pseudogout, or psoriatic arthritis), bony or soft tissue malignancy or skin lesions or peripheral neuropathy involving the lower extremities, cardiopulmonary disease which limits walking more than knee pain. Knee instability defined as report of knee bucking or locking within the past month of the study knee, major neurologic deficit that affects gait, psychiatric illness that limits informed consent, and parkinsonism. Cancer

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A+ HA(tm)<br>20 ml oral solution of hyaluronic acid mixture 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<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 |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | A normalized score (0-100, 0 indicating extreme symptoms and 100 indicating no symptoms) was calculated. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | A normalized score (0-100, 0 indicating extreme symptoms and 100 indicating no symptoms) was calculated. | 8 weeks | 
| SF-36 | each item was recorded into score with a 0 to 100 range. Higher scores mean a better outcome. | 8 weeks | 
| Chinese version Pittsburgh Sleep Quality Index (CPSQI) | Total score of CPSQI from 0 (better) to 21 (worse) was used as the indicators of sleep quality | 8 weeks |