A Validation Study of Sodium Hyaluronate in Patients With Periarthritis of Shoulder
试验速览
- 阶段
- 不适用
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Changes of Pain Rating Scale（NRS）
研究概览
简要总结
Alge as a positive control drug, in patients with periarthritis of shoulder, in a double-blind, controlled manner to study the safety and treatment of Sodium Hyaluronate
详细描述
Aerzhi as a positive control drug, in patients with periarthritis of shoulder, in a double-blind, controlled manner to study the safety and treatment of Sodium Hyaluronate. Once a week, continuous treatment for 5 weeks
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)
盲法说明
The evaluation of the subjects will be conducted by the blind researchers. The IMP administration of the subjects will be conducted by non blind researchers or legal staff authorized by the principal investigator (PI)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Based on clinical symptoms and range of motion (ROM) limitation: abduction is not more than 135 degrees, external rotation is not more than 20 degrees or the maximum internal rotation arrives at the first lumbar spinous process (the tip of the patient can touch) to diagnose the patients with periarthritis of shoulder
- •Signs and symptoms were repeated for 12 weeks or more at the time of signing informed consent (12 weeks or more)
- •At zeroth weeks, according to the pain assessment scale (NRS, range: 0-10), the subjects' self rating pain score was no less than 5 points
- •Fully informed consent signed voluntarily informed consent
排除标准
- •Lead to other diseases of shoulder disorders, such as acute rotator cuff tear, calcific tendinitis. If the diagnosis is necessary, the MRI scan is performed
- •Patients who are not suitable for medical treatment (e.g. patients with surgical indications)
- •Patients who received opioids before the first study of the drug
- •Patients who received the following or more treatment within 2 weeks before the first use of the drug(Bilateral or unilateral shoulder joint movement therapy/Treatment of periarthritis of shoulder with proprietary Chinese Medicine)
- •Patients who received the following or more treatment within 4 weeks before the first use of the drug(Corticosteroids were injected locally or bilaterally on either side of the shoulder or on the other side of the shoulder (bilateral or unilateral shoulder joint);Oral corticosteroids, suppositories or intravenous preparations for the treatment of glucocorticoids)
- •Treatment of shoulder joint (bilateral or unilateral) with hyaluronic acid injection within 24 weeks before the first study of the drug
- •It is diagnosed as rheumatic disease
- •Patients unable to assess their clinical manifestations
- •Skin disease or skin infection around the injection site can cause the risk of injection infection
- •Severe heart disease, renal failure, hematologic diseases, or diabetes mellitus
- •There is a history of hypersensitivity to any component in the research drug (IMP)
研究组 & 干预措施
Sodium Hyaluronate group
Treatment of periarthritis of shoulder with Sodium Hyaluronate
干预措施: Sodium Hyaluronate (Drug)
Aerzhi group
Treatment of periarthritis of shoulder with Aerzhi
干预措施: Aerzhi (Drug)
结局指标
主要结局
Changes of Pain Rating Scale（NRS）
时间窗: Fifth weeks after medication
At fifth weeks, subjects reported changes in NRS pain scores compared to baseline
次要结局
- The number of adverse events(Fifth weeks after medication)
研究者
pengzhang
Doctor
Peking University People's Hospital