Zushima Plaster for Treating Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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Zushima Plaster for Patients in Knee Osteoarthritis: a Random, Positive Drug Controlled, Multi-center Clinical Research

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Zushima plaster with high dose
* Drug: Zushima plaster with low dose
* Drug: Indometacin Cataplasms


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 40-75; Unilateral or bilateral knee OA, confirmed radiographically; Patients taking oral NSAIDs prior to the breakthrough period will be permitted; VAS pain score is or above 20mm. Exclusion Criteria: Knee is swollen and hot; Allergic to any ingredient in Girald Daphne Bark Plaster (Girald Daphne Bark, Lithargite, Linseed oil, Red lead) ; Congestive Heart Failure and Edema; Advanced renal disease; Knee joint skin is burst or skin disease or allergies.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High dose group<br>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. | Drug: Zushima plaster with high dose<br>* Patients in high dose Zushima plaster group will use Zushima plaster topically on knee(s) for 24h per day.<br>|
| Active Comparator: Low dose group<br>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. | Drug: Zushima plaster with low dose<br>* Patients in low dose Zushima plaster group will use Zushima plaster topically on knee(s) for 12h per day.<br>|
| Active Comparator: Controlled group<br>Indometacin Cataplasms will be used topically on the knee for 24h per day | Drug: Indometacin Cataplasms<br>* Patients in Indometacin Cataplasms group will use Indometacin Cataplasms on knee(s)for 24h per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment |  | Week 2. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Osteoarthritis