Randomized controlled trial and metabolomic mechanism of Lingbao Huxin Pill in the treatment of stable angina (Qi deficiency and blood stasis syndrome)

Not Applicable

Conditions: stable angina

Registration Number: ITMCTR2200005632

Lead Sponsor: Shuguang Hospital of Shanghai University of Traditional Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Inclusion criteria for the stable angina group
(1) Meet the western medical diagnostic standards for stable type angina of coronary heart disease;
(2) Meet the TCM dialectical standards for qi deficiency and blood stasis;
(3) Patients with angina attacks 2 or more times a week;
(4) The Canadian Cardiovascular Society (CCS) graded angina with gradeS I.-III.;
(5) Age 18-80 years old (including 18 and 80 years old);
(6) Sign the informed consent form.
2.Criteria for inclusion in the acute myocardial infarction group
(1) Meet the diagnostic criteria of Western medicine for acute myocardial infarction;
(2) Meet the TCM dialectical standards for qi deficiency and blood stasis;
(3) The onset time is less than 6 hours, and the coronary angiography is confirmed by emergency coronary angiography to confirm the single, double or triple vascular lesions of the coronary arteries and PCI;
(4) Age 18-80 years old (including 18 and 80 years old);
(5) Sign an informed consent form.
3.Inclusion criteria for health groups
(1) Determined to be in good health by the Physical Examination Center of Shuguang Hospital;
(2) Meet the physical and mental health standards determined by the WHO;
(3) Age 18-80 years old (including 18 and 80 years old);
(4) Sign the informed consent form.

Exclusion Criteria

(1) Pregnant, planned pregnancy or lactating women;
(2) Those with serious cardiovascular diseases such as refractory heart failure, cardiogenic shock, and severe valvular heart disease;
(3) Chest pain caused by lesions other than coronary artery disease, such as psychosis, severe neurosis, hyperthyroidism, biliary syndrome, gastric and esophageal reflux, aortic dissection, etc.;
(4) Complicated with uncontrolled grade III hypertension (systolic blood pressure = 180mmHg and/or diastolic blood pressure =110mmHg), severe arrhythmias;
(5) Severe respiratory diseases such as severe pulmonary insufficiency (PaO2<60mmHg).
(6) Patients with severe liver and kidney diseases such as hepatic insufficiency (the level of alanine aminotransferase or aspartate aminotransferase is more than 2 times higher than normal), renal insufficiency (creatinine level is more than 2 times higher than normal);
(7) There are other serious diseases or conditions such as malignant tumors, severe anemia, and severe renal artery stenosis;
(8) Patients who are allergic to the components of the test drug and have severe allergic constitutions;
(9) Those who have participated in clinical research of other drugs in the past 2 months;
(10) Recently, researchers with infections, traumas, etc. have judged that they cannot participate in the study.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TCM syndrome score;

Secondary Outcome Measures

Name	Time	Method
Blood metabolites;Grading of angina;Seattle Angina Scale score;Low density lipoprotein cholesterol;Superoxide dismutase;Echocardiography;Angina symptom score;electrocardiogram;high-density lipoprotein cholesterol;nitric oxide;Hypersensitive C-reactive protein;major adverse cardiovascular event;Triglycerides;Fasting blood glucose;Total cholesterol;