Effect of Acupuncture in Patients With Stable Angina Pectoris: an Open Label, Randomized, Controlled,Multi-center Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- Number of angina attacks
研究概览
简要总结
This trail aims to evaluate the efficacy of acupoints on the specific meridian for chronic stable angina pectoris, compared with acupoints on the other meridian, sham acupoints and waiting-list. And to confirm the specificity of acupoints on meridian.
详细描述
The basis of acupuncture is the theory of meridians and acupoints. Meridian and collaterals internally pertain to viscera, and externally spread over the extremities. An acupoint is the place where the visceral qi and meridian qi distributed in. besides acupoints are the stimulus points and reactive points for acupuncture to treat the diseases. Selecting the acupoints on the specific meridian is the basic principle of acupuncture. Recently, as to the existence of specificity of acupoints on the meridian has been questioned by many researchers. This trial using chronic stable angina pectoris as a carrier, select the acupoints on the hand shao yin heart meridian and hand jue yin pericardium meridian to treat chronic stable angina pectoris. Compared with acupoints on the other meridian and non-acupoints ,aiming to evaluate the efficacy, furthermore ,to confirm the existence of the specificity of acupoints on meridian.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.Meet the diagnostic criteria of ACC/AHA angina pectoris of coronary heart disease.
- •2.35 ≤ age ≤ 80 years of age, both male and female.
- •3.The onset of angina pectoris≥3 months, and the frequency of angina attack≥2 a week.
- •4.Patients signed the informed consent.
排除标准
- •age≤35 or age≥80
- •Pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months.
- •Combined with cardiovascular, digestive, respiratory, urinary, blood, nervous, endocrine system, severe primary disease clinical failed to effectively control the disease.
- •Complicated with mental disorders.
- •allergic constitution or bleeding disorder.
- •Patients accompany with acute coronary syndrome (including acute myocardial infarction, unstable angina), severe arrhythmias ( severe atrioventricular block, ventricular tachycardia, heartbeat influence the flow dynamics in supraventricular tachycardia, heartbeat frequent premature beats especially premature ventricular contractions ), atrial fibrillation, primary cardiomyopathy, valvular heart disease.
- •The blood pressure and blood glucose fail to meet the treatment targets.
- •Cardiovascular disease who had been treated with acupuncture during the previous three months.
- •Currently participating in other clinical trials.
研究组 & 干预措施
acupoints on specific meridian
Acupuncture plus foundation treatment。 We Select specific acpupoints on the heart and pericardium meridian.
干预措施: acupuncture (Other)
acupoints on specific meridian
Acupuncture plus foundation treatment。 We Select specific acpupoints on the heart and pericardium meridian.
干预措施: Basic treatment (Drug)
acupoints on the other meridian
Acupuncture plus foundation treatment。We choose the acupoints on the other meridian。
干预措施: acupuncture (Other)
acupoints on the other meridian
Acupuncture plus foundation treatment。We choose the acupoints on the other meridian。
干预措施: Basic treatment (Drug)
sham acupoints
Acupuncture plus foundation treatment。We use sham acupoints。
干预措施: acupuncture (Other)
sham acupoints
Acupuncture plus foundation treatment。We use sham acupoints。
干预措施: Basic treatment (Drug)
waiting-list
wait for the treatment，Only basic treatment, We will not treat the participants until they complete all the observations.
干预措施: Basic treatment (Drug)
结局指标
主要结局
Number of angina attacks
时间窗: 16 weeks after inclusion
The frequency of angina attack during 4-week.
次要结局
- The severity of angina ( VAS score)(0 day,4, 8, 12, 16 weeks after inclusion)
- The Seattle Angina Questionnaire ( SAQ ) score(0 day,4, 8, 12, 16 weeks after inclusion)
- Self-rating Depression Scale(0 day,4, 8, 16 weeks after inclusion)
- The dosage of nitroglycerin(0 day,4, 8, 12, 16 weeks after inclusion)
- Six minute walk test(0 day and 4 weeks after inclusion)
- self-rating anxiety scale(0 day,4, 8, 16 weeks after inclusion)
- Dynamic ECG Observation of the changes of ST-T(0 day and 4 weeks after inclusion)
- The incidence of cardiovascular episode during the 4 months(4, 8, 12, 16 weeks after inclusion)