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Through an eight-week randomized, double-blind, placebo-controlled clinical trials formula to evaluate Chinese herbal compound OA2 improve osteoarthritis of efficacy and safety.
This trial was a 8 weeks' randomized, double-blind, placebo-controlled study. The study was approved by the Institutional Review Board of Chung Shan Medical University hospital, and signed informed consent was obtained from each patient. Eighty-one patients of osteoarthritis of knees or hips were enrolled in this study. Inclusion criteria were: age 20 to 80 years; primary osteoarthritis in at least 1 knee, verified radiologically and scored (as normal, minimal, moderate or marked) for joint-space narrowing and marginal osteophytes in the medial, lateral and patellofemoral compartments; at least moderate pain during the 2 weeks before random assignment to treatment, as identified with the Western Ontario and McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale.
Primary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 4.
Secondary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 2; Visual analogue scale (VAS), Quality of life by SF-36, patient global assessment (PGA), at week 2 and 4; The PGA was scored from 0 to 4 (0 representing very good); Biomarkers: Hs-CRP, ESR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCM OA2 | Experimental | TCM OA2 3G BID FOR 8 WEEKS |
|
| PLACEBO | Placebo Comparator | PLACEBO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCM OA2 | Drug | Usage: 3g twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities (WOMAC) | The investigators use WOMAC to compared the difference between the week 8 and week 0 | week 0, week 4, week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale for pain (VAS) | The investigators use VAS to compared the difference between the week 4 and week 0, week 8 and week 0 | week0, week 4 and 8 |
| Physicians Global Assessment to measure quality of life (PGA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei C- C, M.D. | Chung Shan Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University Hospital | Taichung | 402 | Taiwan |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 18, 2019 | |
| Reset | Dec 6, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 18, 2019 | Dec 6, 2019 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| PLACEBO | Drug | Usage: 3g twice daily |
|
The investigators use PGA to compared the difference between the week 4 and week 0, week 8 and week 0
| week0, week 4 and week 8 |
| Quality of life by SF-36 | The investigators use SF-36 to compared the difference between the week 4 and week 0, week 2 and week 0 | week0, week 2 and week 4 |
| High sensitivity C-reactive protein (Hs-CRP) | The investigators use Hs-CRP to compared the difference between the week 8 and week 0 | week0, week 8 |
| Erythrocyte sedimentation rate (ESR) | The investigators use ESR to compared the difference between the week 8 and week 0 | week0, week 8 |