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Evidence-based evaluation study of Yiqi Huoxue Herbs on Improving Cardiopulmonary Exercise Tolerance in patients with stable coronary artery disease and cardiac insufficiency

Evidence-based evaluation study of Yiqi Huoxue Herbs on Improving Cardiopulmonary Exercise Tolerance in patients with stable coronary artery disease and cardiac dysfunction

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084917
Enrollment
Unknown
Registered
2024-05-28
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable coronary artery disease with cardiac insufficiency

Interventions

Experimental group:Conventional western medicine treatment and Yuxintong capsule, 4 capsules/time, 3 times/day
Control group:Conventional western medicine and Yuxintong capsule placebo, 4 pills/time, 3 times/day

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged between 18 and 75 years old, no gender limitation; (2) Patients with stable coronary syndrome, confirmed by coronary angiography or coronary CT angiography to have a =50% stenosis in the coronary arteries, or patients with acute coronary syndrome who have maintained stable condition for a minimum of 3 months following percutaneous coronary intervention (PCI); (3) Patients diagnosed with cardiac insufficiency (chronic heart failure) according to New York Heart Association (NYHA) functional classifications (class II-III), and an ejection fraction greater than 35%; (4) Patients exhibiting symptoms consistent with the TCM diagnostic criteria for qi deficiency and blood stasis syndrome; (5) Patients voluntarily participated in this study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) In conjunction with severe aortic stenosis, acute aortic dissection, acute myocarditis or pericarditis, aneurysm, severe pulmonary hypertension, acute pulmonary embolism, pulmonary infarction, pulmonary bullae, emphysema, respiratory failure and other cardiopulmonary diseases; (2) Acute cerebrovascular disease; (3) Poorly controlled hypertension (systolic blood pressure =160mmHg and diastolic blood pressure =100mmHg); (4) Uncontrolled arrhythmia with clinical symptoms or hemodynamic disturbance; (5) Patients with severe underlying conditions such as liver disease, kidney disease, hematopoietic disorders, acute infectious diseases, mental disorders or other illnesses are not suitable for cardiopulmonary exercise testing; (6) Pregnant women or those planning to become pregnant or lactating women; (7) Major head and chest or abdominal surgery within the past 4 weeks or bleeding tendency; (8) Participation in other clinical trials within the past 1 months; (9) Patients with contraindications for cardiopulmonary exercise testing; (10) Patients undergoing regular extracorporeal counterpulsation therapy; (11) Allergy to the investigational drug or its components.

Design outcomes

Primary

MeasureTime frame
Peak oxygen uptake;

Secondary

MeasureTime frame
Age;Gender;BMI;The Short Form (36) Health Survey;Cardiac ultrasound;Electrocardiogram;Mindasu Heart Failure Scale;Seattle Angina Questionnaire;Serum levels of AMPK, SIRT-1, PGC-1a, ATP, ADP and AMP;SF-6Dv2;occurrence of cardiovascular endpoints throughout the study duration;

Countries

China

Contacts

Public ContactXue Mei

Xiyuan Hospital, China Academy of Chinese Medical Sciences

meiar@126.com+86 135 8180 1296

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026