The Safety Assessment of Pharmacopuncture on Musculoskeletal Patients: a Multi-center, Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 7
- 主要终点
- Incidence of infection cases
研究概览
简要总结
The purpose of this study is to evaluate the safety of pharmacopuncture by observing any adverse events that may occur after pharmacopuncture treatment in with spinal joint disease hospitalized patients at 7 Korean medicine hospitals and analyzing blood test results.
详细描述
This study was an registry observational study, and was conducted in 7 Korean medicine hospitals (160 patients at Jaseng Korean medicine Hospital, 140 patients at Daejeon Jaseng Hospital of Korean Medicine, 140 patients at Bucheon Jaseng Hospital of Korean Medicine, 140 patients at Haeundae Jaseng Korean medicine Hospital, 140 patients at Kyunghee University of Korean medicine Hospital, 140 patients at Kyung Hee University of Korean Medicine Hospital at Gangdong, and 140 patients at Dongguk University Bundang Oriental Hospital).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients with diagnosed spinal joint disease
- •Patients who received pharmacopuncture treatment during hospitalization
- •Patients who are 19 years of age or older and less than 70 years old
- •Patients who agreed to participate in the clinical study and voluntarily given written informed consent
排除标准
- •Patients with difficulty or refusal to give sign written informed consent
- •Patients for whom the researchers judge participation in the clinical study to be difficult
结局指标
主要结局
Incidence of infection cases
时间窗: 1 month
Infection is one of the representative adverse events for subcutaneous and intramuscular interventions. Infection cases will be collected to evaluate the safety of pharmacopuncture.
次要结局
- Number of abnormal cases that appeared on the blood analysis(Day 2, discharge day, 1 month)
- Adverse events(during admission (from day 2 to until discharge), 1 month)
研究者
In-Hyuk Ha, KMD
Hospital director, Research director
Jaseng Medical Foundation