Clinical Study of Herbal Formula in Post PCI Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes.
研究概览
简要总结
We conduct this clinical trial to determine the effects of Xuefu Zhuyu capsule (based on TCM "Zheng Hou" theory) in helping recovery from coronary heart disease(CHD)after PCI and find out whether this kind of effecacy is much better within patients administered with TCM syndrome-based individualized medication.
详细描述
The effectiveness of a Chinese herbal formulae is not completely based on the disease or some biomedical indexes, but much more on the TCM syndrome(Chinese name:Zheng Hou)which is generalized from patients' TCM signs and symptoms. Thus, conventional medical curative effecacy evaluation system seems not to so fit for TCM clinical studies. Although many clinical studies from Chinese literature have reported the beneficial effects of various of TCM herbal agents in improving symptoms and signs as well as antagonism of specific pathological changes in CHD patients, most of these trials are lack of well-designed methodologies and the reliability of results still remains unclear. Therefore, we designed this clinical trial, with a randomized, placebo controlled way, to evaluate the curative effects of Xuefu Zhuyu capsule(a Chinese herbal medicine)in patients with Post-PCI CHD patients and find out whether this effects will be better displayed within subjects administered with syndrome-based individualized medication.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old
- •Clinical diagnosis of coronary heart disease (confirmed by coronary angiography)
- •Successfully received interventional therapy (PTCA or PCI)
- •belong to TCM blood-stasis syndrome
- •Must be able to swallow tablets
- •Able to give written informed consent
排除标准
- •Symptomatic congestive heart failure(New York Heart Association class III-IV)
- •Females during pregnancy or lactation
- •Serious dysfunction in important organs (liver, lung, kidney，et al)
- •Use of concomitant Chinese herbal medicine
- •Already attend other clinical trial
研究组 & 干预措施
Xuefu Zhuyu Capsules
干预措施: Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules, (Drug)
Sheng Mai Capsules
干预措施: Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules (Drug)
Placebo
干预措施: Placebo of Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules (Drug)
结局指标
主要结局
Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes.
时间窗: 4 weeks
次要结局
- Health related quality of life (Hr-QoL); Changes in serum lipid, inflammatory reaction level and endothelial function status alternations before and after the treatment.(4 weeks)