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Complementary and alternative medicine has been employed over thousands of years to relieve knee Osteoarthritis (OA) pain. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of Knee Osteoarthritis (KOA) Some studies involving animal subjects may explored its mechanism. However, presently, there is a lack of large-sample, multicenter, randomized, controlled trials to evaluate the effects of Xinfeng Capsule treated for KOA. Therefore, the investigators designed a randomized, placebo-controlled, double-blind, multicenter trial to evaluate the effectiveness and safety of Xinfeng Capsule in the treatment of KOA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xinfeng capsule | Experimental | Xinfeng capsule:Three each time, 3 times a day, Oral,for 4 weeks placebo(for glucosamine sulfate capsule): One each time, 3 times a day, Oral,for 4 weeks |
|
| glucosamine sulfate capsule | Active Comparator | glucosamine sulfate capsule: One each time, 3 times a day, Oral,for 4 weeks placebo(for Xinfeng capsule): Three each time, 3 times a day, Oral,for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glucosamine sulfate | Drug | glucosamine sulfate capsule: One each time, 3 times a day, Oral,for 4 weeks placebo(for Xinfeng capsule): Three each time, 3 times a day, Oral,for 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Osteoarthritis Index (WOMAC) | up to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Arthritis pain assessment using the Visual Analog scale (VAS) | baseline,week2,week4 | |
| KOA severity using the Lequesne MG score | baseline,week2,week4 | |
| Erythrocyte sedimentation rate (ESR), C-reactive protein, alkaline phosphatase (ALP), superoxide dismutase (SOD) and serum calcium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Liu | The First Affiliated Hospital of Anhui University of Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Anhui University of Chinese Medicine | Hefei | Anhui | 230031 | China | ||
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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 |
|---|---|
| D005944 | Glucosamine |
| C533622 | xinfeng |
| ID | Term |
|---|---|
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |
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| Xinfeng capsule | Drug | Xinfeng capsule:Three each time, 3 times a day, Oral,for 4 weeks placebo(for glucosamine sulfate capsule): One each time, 3 times a day, Oral,for 4 weeks |
|
| baseline,week4 |
| Bilateral femoral bone mineral density. | baseline,week4 |
| Health assessment of the patient refer to the MOS item short from health survey (SF-36) | baseline,week4 |
| The Taihe County Hospital of Chinese Medicine |
| Taihe Chengguanzhen |
| Anhui |
| 236600 |
| China |
| The Tianchang City Hospital of Chinese Medicine | Tianchang | Anhui | 239300 | China |
| D012216 |
| Rheumatic Diseases |