Acupuncture in Patients With Stable Angina Pectoris (ASAP)

Chengdu University of Traditional Chinese Medicine

Status: Completed

Conditions: Angina, Stable

Treatments: Other: acupuncture; Drug: Basic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01686230

2012CB518501-4

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 404 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

1. age≤35 or age≥80
2. Pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months.
3. Combined with cardiovascular, digestive, respiratory, urinary, blood, nervous, endocrine system, severe primary disease clinical failed to effectively control the disease.
4. Complicated with mental disorders.
5. allergic constitution or bleeding disorder.
6. 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.
7. The blood pressure and blood glucose fail to meet the treatment targets.
8. Cardiovascular disease who had been treated with acupuncture during the previous three months.
9. Currently participating in other clinical trials.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

404 participants in 4 patient groups

acupoints on specific meridian

Experimental group

Description:

Acupuncture plus foundation treatment。 We Select specific acpupoints on the heart and pericardium meridian.

Treatment:

Drug: Basic treatment

Other: acupuncture

acupoints on the other meridian

Active Comparator group

Description:

Acupuncture plus foundation treatment。We choose the acupoints on the other meridian。

Treatment:

Drug: Basic treatment

Other: acupuncture

sham acupoints

Sham Comparator group

Description:

Acupuncture plus foundation treatment。We use sham acupoints。

Treatment:

Drug: Basic treatment

Other: acupuncture

waiting-list

Other group

Description:

wait for the treatment，Only basic treatment, We will not treat the participants until they complete all the observations.

Treatment:

Drug: Basic treatment