A Randomized Controlled Clinical Trial of Effectiveness of Yunnan Baiyao in Improving Fracture Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change of VAS pain scores from baseline after administration
研究概览
简要总结
This will be a randomized, controlled, non-inferiority designed clinical trial. 56 qualified subjects will be selected and allocated 1:1 to Yunnan Baiyao group and celecoxib group. Each subject will be treated for 2 weeks and observed for 12 weeks, which will be lasted for 14 weeks during the whole trial. Yunnan Baiyao group will be given 4 times a day, 2 capsules each time after morning, afternoon and evening meals and before going to bed. One capsule of Baoxianzi will be provided for the first time to be taken at the same time with Yunnan Baiyao Capsule, which will be given continuously for 2 weeks. The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks.
详细描述
his will be a randomized, controlled, non-inferiority designed clinical trial. 56 qualified subjects will be selected and allocated 1:1 to Yunnan Baiyao group and celecoxib group. Each subject will be treated for 2 weeks and observed for 12 weeks, which will be lasted for 14 weeks during the whole trial. Yunnan Baiyao group will be given 4 times a day, 2 capsules each time after morning, afternoon and evening meals and before going to bed. One capsule of Baoxianzi will be provided for the first time to be taken at the same time with Yunnan Baiyao Capsule, which will be given continuously for 2 weeks. The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age of the subject is 20-70 years old;
- •Patients with distal radius fractures (Colles fractures) ;
- •Conservative treatment (closed reduction and fixation) after fracture;
- •Willingness to participate in this study and sign the informed consent form (ICF).
排除标准
- •Pathological fractures such as multiple fractures and cancer;
- •Patients with a history of severe chronic disease, such as hypertension, coronary heart disease, diabetes, tuberculosis, etc.;
- •Patients with endocrine diseases unsuitable for inclusion or other related diseases affecting bone metabolism, such as thyroid diseases of clinical significance as hyperparathyroidism, parathyrometaplasia, Paget's disease, Cushing's syndrome, nephrotic rickets, osteomalacia, rheumatoid arthritis, gout, multiple myeloma, osteogenesis insufficiency, etc.;
- •Complicated with malignant tumor, mental illness and other diseases that doctors think may affect the test process;
- •Currently using bone metabolism regulation drugs, such as teripartide, bisphosphonate, etc.;
- •Had a history of chronic pain and used painkillers daily before enrollment; Nonsteroidal anti-inflammatory drugs, opioids, and physical therapy for pain relief within a week after fracture;
- •pregnant and lactating women;
- •Allergic to Yunnan Baiyao or any excipients and celecoxib, or suffering from contraindications or intolerance indicated by the test drug;
- •continuous use of antibiotics;
- •Patients with coagulation dysfunction, receiving anticoagulant therapy or taking antiplatelet aggregation drugs.
研究组 & 干预措施
Yunnan Baiyao
The Yunnan Baiyao group will be given 4 times a day, 2 capsules each time after morning, afternoon and evening meals and before going to bed. One capsule of Baoxianzi will be provided for the first time to be taken at the same time with Yunnan Baiyao Capsule, which will be given continuously for 2 weeks.
干预措施: Yunnan Baiyao (Drug)
celecoxib
The celecoxib group will be given 1 capsule twice a day after breakfast and dinner for 2 weeks.
干预措施: Celecoxib 200mg (Drug)
结局指标
主要结局
Change of VAS pain scores from baseline after administration
时间窗: within 14 weeks
Pain was measured using a VAS, where the amount of pain recorded ranged from 0 (no pain) to 100 (unbearable pain).
次要结局
- The time for fracture healing(within 14 weeks)
- Changes from baseline in Procollagen I N-Terminal Propeptide (P1NP)(within 14 weeks)
- Changes from baseline in β-C-terminaltelopeptide of typeⅠcollagen (β-CTX)(within 14 weeks)
- Changes from baseline in lumbar bone mineral density (BMD)(within 14 weeks)