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Efficacy and safety of Lingbao Huxin Dan in the treatment of stable coronary heart disease

Efficacy and safety of Lingbao Huxin Dan in the treatment of stable coronary heart disease

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068806
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

Stable coronary heart disease

Interventions

Treatment group:Lingbao Huxin Dan + basic treatment of western medicine

Sponsors

Beijing University of Chinese Medicine (BUCM) Third Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The age was 40-75 years old (including 40 and 75 years old); 2. The diagnostic criteria of stable coronary artery disease in accordance with the "Guidelines for the diagnosis and treatment of stable coronary artery Disease" and "2010 Chinese Consensus on the management of chronic stable coronary artery Disease" jointly published by the Interventional Cardiology Group of Chinese Society of Cardiovascular Disease of Chinese Medical Association in 2018; 3. In accordance with the syndrome differentiation criteria of qi deficiency and blood stasis syndrome in traditional Chinese Medicine (TCM) according to the TCM Diagnosis and Treatment Guidelines for Stable Angina pectoris of Coronary heart Disease (CHD) issued by the Cardiovascular Disease Branch of the Chinese Association of Traditional Chinese Medicine in 2019 and the Guiding Principles for Clinical Research of New Traditional Chinese Medicine (TCM) issued by China Medical Science and Technology Press in 2002. 4. Subjects voluntarily signed informed consent;

Exclusion criteria

Exclusion criteria: 1.Unstable angina or an acute coronary syndrome within the previous 60 days or coronary revascularization procedure (PCI or CABG); 2. Hypertensive patients with high blood pressure (systolic blood pressure >=160mmHg and/or diastolic blood pressure >=100mmHg) after antihypertensive drug treatment 3. Patients with severe arrhythmia (atrial fibrillation with rapid ventricular rate, atrial flutter, paroxysmal ventricular tachycardia, etc.), aortic stenosis, acute aortic dissection, acute myocarditis or pericarditis, aneurysm, severe pulmonary hypertension, acute pulmonary embolism, pulmonary infarction, pulmonary bullae, emphysema, respiratory failure, etc., or heart failure (cardiac function class ? or above). 4. abnormal coagulation function, abnormal liver function (> 2 times the upper limit of normal reference value), and abnormal renal function; 5.serious primary diseases of the liver, kidney, blood, cerebrovascular system, acute infectious diseases, mental disorders, and malignant tumors 6. pregnant, planning pregnancy, or lactating women. 7. Allergic to the test drug or its components. 8. those who participated in other clinical trials within the past 4 weeks. 9. Have taken Chinese medicine preparations (including Chinese patent medicine, decoction, formula granules, etc.) within the past week 10. Other conditions judged by the investigator to be unsuitable for clinical study participation.

Design outcomes

Primary

MeasureTime frame
Chinese Medicine Symptom Score;Angina efficacy score;

Secondary

MeasureTime frame
electrocardiogram;SeattleAnginaQuestionnaiire.SAQ;Quality of life score;

Countries

China

Contacts

Public ContactLiu Ziwang

Beijing University of Chinese Medicine (BUCM) Third Affiliated Hospital

liuziw@163.com+86 131 4137 0708

Outcome results

None listed

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