Osteoarthritis
Conditions
Keywords
Knee Osteoarthritis
Brief summary
The purpose of this study is to further evaluate the clinical efficacy and safety of Zushima plaster for patients in knee osteoarthrosis post-marketing.
Interventions
DRUGZushima plaster with high dose
Patients in high dose Zushima plaster group will use Zushima plaster topically on knee(s) for 24h per day.
DRUGZushima plaster with low dose
Patients in low dose Zushima plaster group will use Zushima plaster topically on knee(s) for 12h per day.
DRUGIndometacin Cataplasms
Patients in Indometacin Cataplasms group will use Indometacin Cataplasms on knee(s)for 24h per day.
Sponsors
Beijing Hospital of Traditional Chinese Medicine
Beijing Hospital
Beijing Jishuitan Hospital
Beijing Shijitan Hospital, Capital Medical University
Shanghai Municipal Hospital of Traditional Chinese Medicine
Gansu Provincial Hospital
General Hospital of Beijing Military Area
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment | Week 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 2. | 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. |
| the change of Patient's global assessment of disease activity from baseline to posttreatment | 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 | Week 2. | 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. |
| the change of Erythrocyte Sedimentation rate (ESR) from baseline to posttreatment | Week 2. | 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. |
Countries
China
Outcome results
None listed