Therapeutic Evaluation of Treatment With Sinomenine Versus Glucocorticoid for Early Knee Osteoarthritis: A Prospective, Double-Blind, Randomized, Multicenter Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 328
- 主要终点
- total WOMAC score and tibial cartilage volume
研究概览
简要总结
Both glucocorticoid and sinomenine are widely used in the routine clinical treatment of osteoarthritis, but there is still a lack of high level of clinical evidence for the direct comparison of efficacy between the two drugs. This trial aims to evaluate whether intraarticular injection of sinomenine was noninferior to intraarticular injection of glucocorticoid for symptom relief in patients with early knee arthritis, and whether intraarticular injection of sinomenine was superior to intraarticular injection of glucocorticoid for changes in tibial cartilage volume (measured by mean thickness) from baseline compared with intraarticular injection of glucocorticoid. 326 people will participate in the study at 3 different research/medical institutions, with centres competing for inclusion. This trial was designed by random blind method. This trial will last for 2 years and participants will receive 6 injections every 4 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 40 and <
- •Bilateral knee pain lasting for more than 6 months and most of the last month;
- •X-rays showed that Kellgren and Lawrence had grade 2 or 3 knee osteoarthritis.
排除标准
- •Kellgren and Lawrence Level 1 or
- •Radiographs showed that the reduction of the lateral joint space was greater than or equal to the medial joint space.
- •The affected knee had been injected with glucocorticoid or hyaluronic acid within the past 6 months.
- •Have had knee surgery or plan to have joint surgery on the affected knee.
- •Other medical conditions such as: systemic or inflammatory joint diseases (rheumatoid arthritis), history of crystalline or neurological joints, other muscular, joint or nervous system diseases affecting lower limb function.
- •Have a needle phobia.
- •Immunosuppression or acute infection is present.
- •Patients are allergic to the drugs involved in the study.
- •Have or have had cancer or tumours.
- •Have a hemorrhagic disease or are receiving anticoagulant or antiplatelet therapy.
- •History of hyperlipidemia, or plasma total cholesterol ≥6.2mmol/L and triglycerides >2.3mmol/L
- •Have any other medical conditions that do not participate in the study, including contraindications to MRI, such as pacemakers.
- •Body mass Index (BMI) > 40 kg/m
- •Unable to attend all study appointments within 24 months;
- •Inability to understand written and spoken Chinese.
- •Any history of mental and psychological illness.
研究组 & 干预措施
Sinomenine
干预措施: Sinomenine (Drug)
Glucocorticoid
干预措施: Glucocorticoid (Drug)
结局指标
主要结局
total WOMAC score and tibial cartilage volume
时间窗: 24 months after the first injection
24 months after the first injection (1) the change in the total WOMAC score from baseline and whether sinomenine was noninferior to glucocorticoid, and (2) the change in tibial cartilage volume from baseline (on average thickness in mm) and whether sinomenine was noninferior to glucocorticoid.
次要结局
- The Timed Up and Go and 20m walking time(24 months after the first injection)
研究者
Changqing Zhang
Principal Investigator
Shanghai 6th People's Hospital