Acupuncture in Patients With Stable Angina Pectoris

NCT ID: NCT01686230

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2017-07-31

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.

Conditions

Angina, Stable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

acupoints on specific meridian

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

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

In each session, we treat bilaterally, 3 times a week and 2 days off a week, each patient in the acupuncture treatment groups will receive 12 sessions of acupuncture treatment over 4 weeks. The whole study period is 20 weeks including 4-week baseline period,4-week treatment period, and 12-week follow-up period. we will investigate at 0 day,4week,8week,12week,16week after randomization。

Basic treatment

Intervention Type: DRUG

Each group in the basic treatment，Foundation treatment including health education and basic drug therapy.

We recommend lifestyle modification for all patients. Modifications include increasing exercise; limiting alcohol consumption; and weight loss; quit smorking etc.

Basic medication： Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.

acupoints on the other meridian

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

Group Type: ACTIVE_COMPARATOR

acupuncture

Intervention Type: OTHER

In each session, we treat bilaterally, 3 times a week and 2 days off a week, each patient in the acupuncture treatment groups will receive 12 sessions of acupuncture treatment over 4 weeks. The whole study period is 20 weeks including 4-week baseline period,4-week treatment period, and 12-week follow-up period. we will investigate at 0 day,4week,8week,12week,16week after randomization。

Basic treatment

Intervention Type: DRUG

Each group in the basic treatment，Foundation treatment including health education and basic drug therapy.

We recommend lifestyle modification for all patients. Modifications include increasing exercise; limiting alcohol consumption; and weight loss; quit smorking etc.

Basic medication： Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.

sham acupoints

Acupuncture plus foundation treatment。We use sham acupoints。

Group Type: SHAM_COMPARATOR

acupuncture

Intervention Type: OTHER

In each session, we treat bilaterally, 3 times a week and 2 days off a week, each patient in the acupuncture treatment groups will receive 12 sessions of acupuncture treatment over 4 weeks. The whole study period is 20 weeks including 4-week baseline period,4-week treatment period, and 12-week follow-up period. we will investigate at 0 day,4week,8week,12week,16week after randomization。

Basic treatment

Intervention Type: DRUG

Each group in the basic treatment，Foundation treatment including health education and basic drug therapy.

We recommend lifestyle modification for all patients. Modifications include increasing exercise; limiting alcohol consumption; and weight loss; quit smorking etc.

Basic medication： Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.

waiting-list

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

Group Type: OTHER

Basic treatment

Intervention Type: DRUG

Each group in the basic treatment，Foundation treatment including health education and basic drug therapy.

We recommend lifestyle modification for all patients. Modifications include increasing exercise; limiting alcohol consumption; and weight loss; quit smorking etc.

Basic medication： Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.

Interventions

acupuncture

In each session, we treat bilaterally, 3 times a week and 2 days off a week, each patient in the acupuncture treatment groups will receive 12 sessions of acupuncture treatment over 4 weeks. The whole study period is 20 weeks including 4-week baseline period,4-week treatment period, and 12-week follow-up period. we will investigate at 0 day,4week,8week,12week,16week after randomization。

Intervention Type: OTHER

Basic treatment

Each group in the basic treatment，Foundation treatment including health education and basic drug therapy.

We recommend lifestyle modification for all patients. Modifications include increasing exercise; limiting alcohol consumption; and weight loss; quit smorking etc.

Basic medication： Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.

Intervention Type: DRUG

Other Intervention Names

Electro-acupuncture，Massage; health education ， basic drug therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hunan University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

fan-rong liang, Professor

Role: STUDY_CHAIR

Chengdu University of Traditional Chinese Medicine

Locations

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

Countries

China

References

Zhao L, Li D, Zheng H, Chang X, Cui J, Wang R, Shi J, Fan H, Li Y, Sun X, Zhang F, Wu X, Liang F. Acupuncture as Adjunctive Therapy for Chronic Stable Angina: A Randomized Clinical Trial. JAMA Intern Med. 2019 Oct 1;179(10):1388-1397. doi: 10.1001/jamainternmed.2019.2407.

Reference Type: DERIVED

PMID: 31355870 (View on PubMed)

Li D, Yang M, Zhao L, Zheng H, Li Y, Chang X, Cui J, Wang R, Shi J, Lv J, Leng J, Li J, Liang F. Acupuncture for chronic, stable angina pectoris and an investigation of the characteristics of acupoint specificity: study protocol for a multicenter randomized controlled trial. Trials. 2014 Feb 5;15:50. doi: 10.1186/1745-6215-15-50.

Reference Type: DERIVED

PMID: 24499445 (View on PubMed)

Other Identifiers

2012CB518501-4

Identifier Type: -

Identifier Source: org_study_id