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| Name | Class |
|---|---|
| Beijing Hospital of Traditional Chinese Medicine | OTHER |
| Beijing Hospital | OTHER_GOV |
| Beijing Jishuitan Hospital | OTHER |
| Beijing Shijitan Hospital, Capital Medical University |
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The purpose of this study is to further evaluate the clinical efficacy and safety of Zushima plaster for patients in knee osteoarthrosis post-marketing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose group | Active Comparator | High dose of Zushima plaster: a piece of Zushima plaster will be used topically for each knee for 24h per day. Eligible subjects will use a piece of Zushima plaster topically for each knee for 24h per day. |
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| Low dose group | Active Comparator | Low dose of Zushima plaster: a piece of Zushima plaster will be used topically for each knee for 12h per day. Eligible subjects will use a piece of Zushima plaster topically for each knee for 12h per day. |
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| Controlled group | Active Comparator | Indometacin Cataplasms will be used topically on the knee for 24h per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zushima plaster with high dose | Drug | Patients in high dose Zushima plaster group will use Zushima plaster topically on knee(s) for 24h per day. |
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| Measure | Description | Time Frame |
|---|---|---|
| the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment | Week 2. |
| Measure | Description | Time Frame |
|---|---|---|
| the change of Patient's global assessment of disease activity from baseline to posttreatment | Week 2. | |
| the change of WOMAC Osteoarthritis Index from baseline to posttreatment | Week 2. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quan Jiang, MD. PhD. | Rheumatology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital | Beijing | Beijing Municipality | 100053 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 23, 2024 | |
| Reset | Jan 9, 2025 | |
| Release | Apr 13, 2025 | |
| Reset | May 1, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 23, 2024 | Jan 9, 2025 | |||
| Apr 13, 2025 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| OTHER |
| Shanghai Municipal Hospital of Traditional Chinese Medicine | OTHER |
| Gansu Provincial Hospital | OTHER |
| General Hospital of Beijing Military Area | UNKNOWN |
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| Zushima plaster with low dose | Drug | Patients in low dose Zushima plaster group will use Zushima plaster topically on knee(s) for 12h per day. |
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| Indometacin Cataplasms | Drug | Patients in Indometacin Cataplasms group will use Indometacin Cataplasms on knee(s)for 24h per day. |
|
| the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment |
The SF-36 is a generic instrument to assess health-related quality of life. It consists of 36 questions and assesses 8 dimensions: physical functioning, role physical, pain index, general health, vitality, social functioning, role emotional, and mental health index. It also provides 2 summary measures of physical and mental components. The SF-36 score ranges from 0 to 100, with higher scores indicating better health status. |
| Week 2. |
| the change of Erythrocyte Sedimentation rate (ESR) from baseline to posttreatment | ESR, also called a sedimentation rate, is the rate at which red blood cells sediment in a period of one hour. It is a non-specific measure of inflammation. | Week 2. |
| the change of C-reactive protein (CRP) from baseline to posttreatment | Week 2. |
| the change of knee musculoskeletal ultrasound (MSUS) from baseline to posttreatment | MSUS had wisely using in rheumatology practice and research. MSUS includes synovitis classification, synovial hyperplasia classification, articular cavity effusion and bone erosion classification. Specific as follows: Synovitis classification: 0 level, no doppler signal; level 1: three independent point or 2 successive or 1 and 2 in independent dot doppler signal; level 2: doppler signal < 50% of the synovial membrane area; level 3 doppler signal is the synovium in > 50% of the area. Synovial hyperplasia classification: 0 level, no synovial hyperplasia; level 1: synovial hyperplasia of mild, not more than bone surface high attachment; level 2: synovial hyperplasia more than bone surface high wire, but not more than the backbone; level 3: synovial hyperplasia more than bone surface peak wires, and extends along the backbone of the side. Articular cavity effusion and bone erosion classification: adopt binary evaluation, namely 0: normal, 1: abnormal. | Week 2. |
| May 1, 2025 |