Acupuncture in Patients With Stable Angina Pectoris

Not Applicable

Completed

• Conditions: Angina, Stable
• Interventions: Other: acupuncture; Drug: Basic treatment

• Registration Number: NCT01686230
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-17
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 404

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupoints on the other meridian	acupuncture	Acupuncture plus foundation treatment。We choose the acupoints on the other meridian。
acupoints on the other meridian	Basic treatment	Acupuncture plus foundation treatment。We choose the acupoints on the other meridian。
sham acupoints	acupuncture	Acupuncture plus foundation treatment。We use sham acupoints。
acupoints on specific meridian	acupuncture	Acupuncture plus foundation treatment。 We Select specific acpupoints on the heart and pericardium meridian.
acupoints on specific meridian	Basic treatment	Acupuncture plus foundation treatment。 We Select specific acpupoints on the heart and pericardium meridian.
sham acupoints	Basic treatment	Acupuncture plus foundation treatment。We use sham acupoints。
waiting-list	Basic treatment	wait for the treatment，Only basic treatment, We will not treat the participants until they complete all the observations.

Primary Outcome Measures

Name	Time	Method
Number of angina attacks	16 weeks after inclusion	The frequency of angina attack during 4-week.

Secondary Outcome Measures

Name	Time	Method
The severity of angina ( VAS score)	0 day,4, 8, 12, 16 weeks after inclusion	The VAS score evaluation angina pain severity
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	Six minute walk test in the evaluation of exercise tolerance
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	Dynamic electrocardiogram in six minute walk test to do
The incidence of cardiovascular episode during the 4 months	4, 8, 12, 16 weeks after inclusion	The incidence of cardiovascular episode during the 4 months(develop into unstable angina, acute myocardial infarction, death)

Trial Locations

Locations (1)

Chengdu University of Traditional Chinese Medicine; 🇨🇳 Chengdu, Sichuan, China