A Post-marketing Evaluation of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy
研究概览
详细说明
Cervical radiculopathy is a distinct consideration in the evaluation of any patients who have neck pain and may be defined simply as an abnormality of a nerve root which originates in the cervical spine. The initial approach to the management of cervical spondylopathic radiculopathy is nearly the same as that of nonspecific neck or back pain that can be found in most patients. Conservative treatments include non-steroidal anti-inflammatory drugs (NSAIDs), narcotics, muscle relaxants, physical therapy and transcutaneous electrical nerve stimulation (TENS). The main objectives of conservative treatments are to relieve pain, improve function and improve health-related quality of life. However, these treatments for cervical radiculopathy are limited by their modest effectiveness. Surgical treatment for cervical disc disease is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. In terms of pharmacotherapy, there is generally no randomized, placebo-controlled trial available comparing standard nonsurgical treatment. Therefore, care plans should be designed principally based on accumulated experience, the services available locally, and the respective preferences of patients. Treatment plans are developed to alleviate pain, improve function, and prevent recurrences.
As a complementary and alternative medicine (CAM), herbal medicines have the potential to avoid the adverse effects of medications and surgery.According to the basic theory of traditional Chinese medicine (TCM), the obstruction of Qi flow and blood circulation in the neck area caused by pathogenic factors, such as "Feng"(wind), "Han"(cold), "Shi"(dampness), invading the neck induces cervical degenerative disc diseases which are the cause of cervical radiculopathy. According to the four traditional methods of diagnosis -observation, listening, interrogation, and pulse-taking, TCM doctors can analyze the specific pathogenic factors which cause neck pain. Accordingly they can then prescribe herbal formulae based on the effect and the main indications according to the principles of Chinese medicine. Natural substances, including herbal medicines, have been used to promote healing and alleviate neck pain in western countries. Previous studies have demonstrated that some active substances in herbal medicine can promote Qi flow and blood circulation to alleviate pain.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Shanghai
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Shanghai、Shanghai、中国、200032
- 招聘中
- Longhua Hospital, Shanghai university of TCM
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首席研究员:
- Yongjun Wang, Dr
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接触:
- Wen Mo, Dr
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副研究员:
- Wen Mo, Dr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- clinical diagnosis of chronic neck pain since at least 3 months and complaints for a maximum duration of 5 years.
- average pain intensity of the last 7 days more or equal to 25 points measured by a Neck Disability Index.
- intellectual and physical ability to participate in the study. informed consent.
- One positive result of Brachial Plexus Traction Test, Cervical compression test or Cervical distraction test
Exclusion Criteria:
- cervical pain related to malignancy
- cervical pain due to an accident
- inflammatory joint disorders
- previous spine surgery
- protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology
- actually doing or planning to do other regular physical exercise during the study with possible positive effects on neck pain - such as swimming, yoga, pilates, tai chi, etc.
- use of pain drugs for other diseases (> 1x/week)
- pregnancy
- severe chronic or acute disease interfering with therapy attendance
- alcohol or substance abuse
- participation in another clinical trial in the last 6 months before study entry
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Qishe Pill
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药丸,3.75 克,每天两次,四个星期
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
疼痛严重程度(用视觉模拟量表,VAS 测量)
大体时间:2周时基线的变化
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在操作上,VAS 分数显示为一条水平线,长度为 100 毫米,词描述符固定在每一端。
患者在线上标记他们感觉到的点代表他们对当前疼痛的感知。
然后通过测量从线的左手端到患者标记的点的毫米数来确定 VAS 分数。
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2周时基线的变化
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疼痛严重程度(用视觉模拟量表,VAS 测量)
大体时间:4 周时基线的变化
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在操作上,VAS 分数显示为一条水平线,长度为 100 毫米,词描述符固定在每一端。
患者在线上标记他们感觉到的点代表他们对当前疼痛的感知。
然后通过测量从线的左手端到患者标记的点的毫米数来确定 VAS 分数。
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4 周时基线的变化
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
SF-36
大体时间:2周时基线的变化
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综合功能状态
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2周时基线的变化
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颈椎残疾指数(NDI)
大体时间:2周时基线的变化
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综合功能状态
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2周时基线的变化
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SF-36
大体时间:4 周时基线的变化
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综合功能状态
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4 周时基线的变化
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颈椎残疾指数(NDI)
大体时间:4 周时基线的变化
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综合功能状态
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4 周时基线的变化
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肾功能检查
大体时间:4 周时基线的变化
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4 周时基线的变化
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肝功能检查
大体时间:4 周时基线的变化
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4 周时基线的变化
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心电图
大体时间:4 周时基线的变化
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4 周时基线的变化
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潜血
大体时间:4 周时基线的变化
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4 周时基线的变化
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尿常规
大体时间:4 周时基线的变化
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4 周时基线的变化
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血常规
大体时间:4 周时基线的变化
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4 周时基线的变化
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Number of participants with Concomitant medication
大体时间:4 weeks
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4 weeks
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Number of participants with Adverse Events
大体时间:4 weeks
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4 weeks
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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芪参丸的临床试验
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Intec Pharma Ltd.未知
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Intec Pharma Ltd.未知帕金森病美国, 西班牙, 意大利, 以色列, 波兰, 英国, 保加利亚, 德国, 斯洛伐克, 乌克兰