Research on the Clinical Effect of Shuanghe Decoction in Treating Unstable Angina.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 主要终点
- Mortality
研究概览
简要总结
This study evaluates the clinical efficacy of Shuanghe Decoction in the treatment of unstable angina. All of the patients will be divided into 2 arms randomly. One of the arms will be treated by conventional western medicine, and the other one will be treated by Shuanghe Decoction at the base of conventional western medicine.
详细描述
Shuanghe Decoction has the function of supplementing Qi and activating blood circulation, which will be used to treat patients with Qi deficiency and blood stasis syndrome.
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with coronary heart disease through coronary angiography or coronary CTA;
- •Patients have at least one of these symptoms:
- •The stability of the nature of angina pectoris changes, that is, frequent attacks of angina pectoris, serious degree and prolonged duration;
- •Angina pectoris during rest;
- •The recent occurrence of angina pectoris caused by mild physical activity in the last month.
排除标准
- •Patients diagnosed with stable angina; Patients with acute myocardial infarction; Chest pain caused by congenital heart disease, valvular heart disease, severe neurosis or arrhythmia; The heart function grade is III or IV; Patients with acute cerebral infarction; Patients complicated with other serious primary diseases; Patients with acute infection in recent 2 weeks; Uncontrolled hypertension (the resting blood pressure >160/95mmHg within one week); Diabetics emerged with serious diabetic complications; Patients can't finish the questionnaire due to abnormal mental and nervous or mental disorders; Pregnant or lactating women.
研究组 & 干预措施
Qi deficiency and blood stasis
Patients in this group will be treated by Shuanghe Decoction at the base of conventional western medicine.
干预措施: Anti-Platelet Drugs (Drug)
Qi deficiency and blood stasis
Patients in this group will be treated by Shuanghe Decoction at the base of conventional western medicine.
干预措施: Lipid Regulating Drugs (Drug)
Qi deficiency and blood stasis
Patients in this group will be treated by Shuanghe Decoction at the base of conventional western medicine.
干预措施: Coronary Vasodilator (Drug)
Qi deficiency and blood stasis
Patients in this group will be treated by Shuanghe Decoction at the base of conventional western medicine.
干预措施: Shuanghe Decoction (Drug)
Conventional western medicine
Patients in this group will be treated by conventional western medicine, including anti-platelet drugss，lipid regulating drugs, coronary vasodilator, etc.
干预措施: Anti-Platelet Drugs (Drug)
Conventional western medicine
Patients in this group will be treated by conventional western medicine, including anti-platelet drugss，lipid regulating drugs, coronary vasodilator, etc.
干预措施: Lipid Regulating Drugs (Drug)
Conventional western medicine
Patients in this group will be treated by conventional western medicine, including anti-platelet drugss，lipid regulating drugs, coronary vasodilator, etc.
干预措施: Coronary Vasodilator (Drug)
结局指标
主要结局
Mortality
时间窗: Six months after drug intervention
Death caused by cardiovascular disease
次要结局
- The incidence of myocardial infarction or heart failure(Six months after drug intervention)
- Myocardial enzymes(At baseline and 4 weeks after drug intervention)
- Treadmill exercise test(At baseline and 4 weeks after drug intervention)
- Blood lipid(At baseline and 4 weeks after drug intervention)
研究者
Jun Li
Chief Physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences