Efficacy and Safety Evaluation of Yangxin Dawaimixike Migao in the Treatment of Chronic Stable Angina Pectoris (Qi Stagnation and Blood Stasis Syndrome): A block randomized, double-blind, double&#

Phase 4

Not yet recruiting

• Conditions: Chronic Stable Angina Pectoris (Qi Stagnation and Blood Stasis Syndrome)

• Registration Number: ITMCTR2000002927
• Lead Sponsor: Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Refer to the Guidelines for the Diagnosis and Treatment of Chronic Stable Angina Pectoris issued by the Chinese Medical Association in 2007, 2012 ACP / ACCF / AHA / AATS / PCNA / STS (Guidelines for the Diagnosis and Management of Stable Ischemic Heart Disease: American Cardiology Foundation / American Heart Association / American Medical Association / American Thoracic Surgery Association / American Cardiovascular Preventive Care Association / American Cardiovascular Angiography and Intervention Association / American College of Thoracic Surgeons) Diagnosis of Stable Ischemic Heart Disease: A Clinical Practice Guide The 2013 ESC Stable Coronary Artery Disease Management Guidelines were developed to diagnose coronary heart disease if one of the following is met:
(1) Have a history of myocardial infarction for more than 3 months;
(2) History of coronary stent implantation or coronary bypass;
(3) Coronary angiography (results suggesting that at least one coronary artery is stenoses with a luminal stenosis of >=50% or coronary CTA indicates luminal stenosis of >=50% or moderate;
(4) Those diagnosed as having coronary heart disease by radionuclide examination or exercise plate electrocardiogram.
2. Activity treadmill exercise test (using the improved Bruce scheme), the total exercise time (TED) during the introduction period and the time of enrollment is between 3 and 7 minutes, the difference is within 20%. (This criterion can be ignored for non-table subjects);
3. Meet the diagnostic criteria for chronic stable angina pectoris: subjects with a history of angina pectoris=3 months and no significant changes in the degree, frequency, nature and evoking factors of angina pectoris;
4. Canadian Cardiovascular Society (CCS) angina pectoris severity rating I to III;
5. TCM syndrome differentiation for Qi stagnation and blood stasis syndrome;
6. Aged 18 to 79 years, and the age range of test subject who having treadmill exercise test should be controlled fall down in the range of 18-70 years;
7. Sign the informed consent.

Exclusion Criteria

1. Patients with severe cardiopulmonary insufficiency (cardiac function III, IV, severe abnormal pulmonary function);
2. Poor hypertension control (systolic blood pressure>=160mmHg or diastolic blood pressure>=100mmHg after treatment);
3. Combined liver and kidney damage, ALT, AST>=1.5 ULN, or Cr> ULN; combined with serious primary diseases such as hematopoietic system
4. Within 3 months after interventional treatment of acute myocardial infarction;
5. People who use pacemakers;
6. Pregnant or lactating women or those with a pregnancy plan;
7. People with allergies or allergies to known ingredients of the research drug;
8. Chest pain caused by other reasons (moderate or higher anemia, hyperthyroidism, etc.);
9. Participants in other clinical drug trials within the past month;
10. According to investigator's judgment, think that it is not suitable to participate in clinical research;
11. Other reasons that affect the change of ST-T in ECG, such as myocardial hypertrophy, left bundle branch block, etc.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified