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To assess TCI633 probiotics on pain relief and functional improvement in osteoarthritis
This is a double-blind and randomized study. Subjects are informed to consume the samples before meals in the morning every day. The clinical and radiological diagnosis of osteoarthritis of the knee is evaluated by the doctor. The blood samples and questionnaires are collected at every visit of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| TCI633 | Experimental | Testing product |
|
| Type 2 collagen | Active Comparator | Known drug for OA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Blank |
| |
| TCI633 |
| Measure | Description | Time Frame |
|---|---|---|
| KL Grade (evaluated by doctor) | Pain relief and functional improvement in osteoarthritis | Change from baseline at 6 months |
| WOMACâ„¢ Osteoarthritis Index | The questionnaire includes three-part: i) join pain (five questions); ii) joint stiffness (two questions); and, iii) physical functions of joints (seventeen questions). Each question is scored 0-4. Low to high WOMAC scores represent slight to severe OA symptoms. The lower scores mean a better outcome. | Change from baseline at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood C-terminal telopeptide of collagen type II (CTX-II) level | To measure the level of CTX-II in blood | Change from baseline at 6 months |
| Blood C-reactive protein (CRP) level | To measure the level of CRP in blood |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ting-Ming Wang, Doctor | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Dietary Supplement |
Probiotics |
|
| Type 2 collagen | Drug | Positive control group |
|
| Change from baseline at 6 months |