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| Name | Class |
|---|---|
| TOP Pharm & Medicalware | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A+ HA(tm) | Experimental | 20 ml oral solution of hyaluronic acid mixture in a bottle. Administration with 250~500 ml water under fasting condition in the morning. |
|
| Placebo | Placebo Comparator | 20 ml oral solution without active ingredients in a bottle. Administration with 250~500 ml water under fasting condition in the morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A+ HA(tm) | Dietary Supplement | oral solution of hyaluronic acid mixture |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shyu-Jye Wang, MD | China Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TOP Pharm. & Medicalware | Taichung | Taiwan |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Placebo |
| Dietary Supplement |
oral solution with no-active ingredients |
|
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 |
| D012216 |
| Rheumatic Diseases |