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The goal of this clinical trial is to investigate the effect of oral hyaluronate in patients with knee osteoarthritis. The main question it aims to answer is: the therapeutic effect in the combined treatment of oral nutritional supplement based on hyaluronic acid with hyaluronic acid intra-articular Injection on symptomatic knee osteoarthritis. Researchers will compare it to those who receive only hyaluronic acid injection to see if the combined treatment is better.
Participants will receive a total of three months of oral hyaluronate or placebo agents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral hyaluronate plus hyaluronate knee injection | Experimental | oral hyaluronate plus hyaluronate knee injection |
|
| hyaluronate knee injection | Placebo Comparator | hyaluronate knee injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral hyaluronate and injection | Drug | The patient receives oral hyaluronate and hyaluronate injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) aim to reveal pain, stiffness and function of the knee, the minimum and maximum values are 0 and 68, and a higher score mean a worse outcome. | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| knee strength | knee extension and flexion torque detected by isokinetic machine | From enrollment to the end of treatment at 12 weeks |
| Timed up and go test | the time needed for a patient sits on a chair, stands up walks for 3 meters, and then go back down |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Veterans General Hospital | Taichung | Taiwan | 40705 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24899570 | Result | Nelson FR, Zvirbulis RA, Zonca B, Li KW, Turner SM, Pasierb M, Wilton P, Martinez-Puig D, Wu W. The effects of an oral preparation containing hyaluronic acid (Oralvisc(R)) on obese knee osteoarthritis patients determined by pain, function, bradykinin, leptin, inflammatory cytokines, and heavy water analyses. Rheumatol Int. 2015 Jan;35(1):43-52. doi: 10.1007/s00296-014-3047-6. Epub 2014 Jun 5. |
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The patients we recruited are not willing to share their individual data
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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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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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both the patients and the investigators were blinded to the agent patients took
| hyaluronate injection | Drug | The patient receives hyaluronate injection only |
|
| From enrollment to the end of treatment at 12 weeks |
| D012216 |
| Rheumatic Diseases |