Zushima Plaster for Patients in Knee Osteoarthritis: a Random, Positive Drug Controlled, Multi-center Clinical Research
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment
研究概览
简要总结
The purpose of this study is to further evaluate the clinical efficacy and safety of Zushima plaster for patients in knee osteoarthrosis post-marketing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
High dose group
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.
干预措施: Zushima plaster with high dose (Drug)
Low dose group
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.
干预措施: Zushima plaster with low dose (Drug)
Controlled group
Indometacin Cataplasms will be used topically on the knee for 24h per day
干预措施: Indometacin Cataplasms (Drug)
结局指标
主要结局
the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment
时间窗: Week 2.
次要结局
- 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(Week 2.)
- the change of Erythrocyte Sedimentation rate (ESR) 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.)
研究者
Juan Jiao
Attending Doctor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences