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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005632
Enrollment
Unknown
Registered
2022-02-10
Start date
2022-02-20
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

stable angina

Interventions

Health group:no
Treatment group:Lingbao Huxin Pill + Conventional Western Medicine
Group of acute myocardial infarction:no

Sponsors

Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
TCM syndrome score;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactXiaolong Wang
rxfzdl@163.com13501991450

Outcome results

None listed

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