Acupuncture in Patients With Stable Angina Pectoris

Angina, Stable Clinical Trial

— ASAP  

Official title:

Effect of Acupuncture in Patients With Stable Angina Pectoris: an Open Label, Randomized, Controlled,Multi-center Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686230
• Other study ID #: 2012CB518501-4
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: July 2017

Study information

• Verified date: February 2020
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable

Intervention

Other:
• 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?

Drug:
• 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.

Locations

Country	Name	City	State
China	Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine	Hunan University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of angina attacks	The frequency of angina attack during 4-week.	16 weeks after inclusion
Secondary	The severity of angina ( VAS score)	The VAS score evaluation angina pain severity	0 day,4, 8, 12, 16 weeks after inclusion
Secondary	The dosage of nitroglycerin		0 day,4, 8, 12, 16 weeks after inclusion
Secondary	Six minute walk test	Six minute walk test in the evaluation of exercise tolerance	0 day and 4 weeks after inclusion
Secondary	Dynamic ECG Observation of the changes of ST-T	Dynamic electrocardiogram in six minute walk test to do	0 day and 4 weeks after inclusion
Secondary	The Seattle Angina Questionnaire ( SAQ ) score		0 day,4, 8, 12, 16 weeks after inclusion
Secondary	self-rating anxiety scale		0 day,4, 8, 16 weeks after inclusion
Secondary	The incidence of cardiovascular episode during the 4 months	The incidence of cardiovascular episode during the 4 months(develop into unstable angina, acute myocardial infarction, death)	4, 8, 12, 16 weeks after inclusion
Secondary	Self-rating Depression Scale		0 day,4, 8, 16 weeks after inclusion