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Efficacy and safety of Yianning pills in the treatment of coronary heart disease stable angina pectoris (Deficiency of qi and blood combined with deficiency of liver and kidney) : a randomized, double-blind, positive-drug parallel control, multi-center clinical trial of TCM variety protection

Efficacy and safety of Yianning pills in the treatment of coronary heart disease stable angina pectoris (Deficiency of qi and blood combined with deficiency of liver and kidney) : a randomized, double-blind, positive-drug parallel control, multi-center clinical trial of TCM variety protection - Clinical trial of Yianning Pill in treating stable angina pectoris of coronary heart Disease (Deficiency of Qi and Blood combined with deficiency of liver and kidney)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060283
Enrollment
Unknown
Registered
2022-05-25
Start date
2022-05-14
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Coronary heart disease stable angina pectoris

Interventions

Experimental group:Experimental group: Yianning pill, specification: 3.1g/18 pills, orally, 18 pills each time, twice a day, Xinyuan capsule simulator, specification: 0.3g/ tablet, orally, 4 pills a t
Eight weeks
The control group:Control group: Yianning Pill simulator, specification: 3.1g/18 pills, orally, 18 pills each time, twice a day, Xinyuan capsule, specification: 0.3g/ pill, orally, 4 pills a time, 3 t
The treatment course lasted for 8 weeks.

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for stable angina pectoris of coronary heart disease; 2. Conforming to the syndrome differentiation standard of deficiency of both qi and blood combined with deficiency of liver and kidney in traditional Chinese medicine; 3. The Canadian Society of Cardiovascular Diseases (CCS) classification of angina pectoris severity falls into grades I to III; 4. 2 times/week <= Number of angina attacks <= 6 times/day; 5. Positive results of treadmill exercise testing during the screening period (only applicable to subjects who need to undergo treadmill exercise testing); 6. Age: 35 to 70 years old (including 35 and 70 years old), regardless of gender; 7. Fully informed and willing to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Any one of the following: severe cardiovascular and cerebrovascular disease (with a history of cerebrovascular accident, acute myocardial infarction, or heart failure within 6 months, grade IV cardiac function, within 6 months after revascularization; large aneurysm or dissecting aneurysm; atrioventricular block above grade II, sick sinus syndrome, and other malignant or potentially malignant cardiac arrhythmias); Hypertrophic cardiomyopathy and other types of cardiomyopathy; Aortic valve stenosis and other heart valve diseases; Congenital heart disease; Constrictive pericarditis, pericardial tamponade, elevated intracranial pressure, cerebral hemorrhage, or head injury; 2. Pulmonary embolism; Respiratory failure; Chronic renal insufficiency and immunodeficiency diseases; Abnormal liver and kidney function ALT, AST >= 1.5 times the upper limit of normal value, Cr >= 1.5 times the upper limit of normal value; 3.There are other diseases that prohibit treadmill exercise testing: active endocarditis; Symptomatic aortic stenosis; Decompensated heart failure; Acute pulmonary thrombosis or pulmonary infarction; Acute non cardiac dysfunction affects or is exacerbated by exercise testing; Acute myocarditis or pericarditis; Physical disorders that affect safety or amount of exercise (only applicable to subjects who need to undergo a treadmill exercise test); 4. Poor control of hypertension (systolic blood pressure >= 160mmHg or diastolic blood pressure >= 100mmHg after treatment); Fasting blood glucose>8 mmol/L; 5. Use Chinese medicine or traditional Chinese patent medicines and simple preparations that has therapeutic effect on stable angina pectoris of coronary heart disease within one week; 6. Using antiplatelet and anticoagulant drugs simultaneously; 7. Persons with physical or mental illness who are unable to cooperate (such as blindness, deafness, deafness, intellectual impairment, mental disorder, etc.), or serious diseases that affect survival (such as tumors, etc.); 8. Those who are suspected or have a history of alcohol or drug abuse; 9.Pregnant or lactating women or those who are unwilling to take contraceptive measures during the trial and within 1 month after the end of the trial; 10. Participated in another drug study within three months before enrollment; 11. Allergic constitution or allergy to known ingredients of the drug; 12.The researcher determined that there were other factors that were not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Change in total score of the Seattle Angina Scale from baseline;

Secondary

MeasureTime frame
Plate motion test;Nitroglycerin stop rate;Classification of angina pectoris severity;Seattle Angina pectoris scale score item (degree of physical activity limitation, angina pectoris stable state, angina pectoris attack) score changes from baseline;TCM syndrome effect;12 lead EKG;

Countries

China

Contacts

Public ContactLiu Hongxu

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

ybkj345@126.com+86 13501161583

Outcome results

None listed

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