Clinical Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine (CSCD-TCM)

Tianjin University of Traditional Chinese Medicine

Status: Unknown

Conditions: Atherosclerotic Heart Disease With Angina Nos

Treatments: Drug: Chinese patent medicine

Study type: Observational

Funder types: Other

Identifiers

NCT04022031

CSCD-TCM

Details and patient eligibility

About

A prospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.Collect primary and secondary efficacy indicators such as the incidence of cardiovascular events, using clinical samples to detect genomics, proteomics, metabolomics, intestinal flora and sclerotia.To explore the clinical efficacy of Chinese patent medicine in the treatment of coronary heart disease with angina pectoris, and provide reliable data support for its clinical application.

Enrollment: 12,400 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntarily participate, understand and sign the informed consent form;
2. Age 35-75 years old, gender is not limited;
3. Patients with coronary heart disease and angina pectoris in the Department of Cardiology or Outpatient Department, the diagnosis of angina pectoris meets the diagnostic criteria of Western medicine and the standard of TCM syndrome differentiation;
4. Patients who met the criteria for drug treatment, the exposed group was treated with traditional Chinese medicine combined with Western medicine, and the non-exposed group was treated with Western medicine alone.

Exclusion criteria

1. Combined with other heart diseases, neurosis, menopausal syndrome, hyperthyroidism, cervical or vertebral artery type cervical spondylosis, gastro-oesophageal reflux disease or esophageal hiatus hernia may cause chest pain;
2. Patients with severe symptoms and uncontrollable angina pectoris, with acute myocardial infarction, heart failure, myocarditis, cardiomyopathy, severe heart valve disease, liver failure or renal failure, malignant tumors and serious metabolic diseases;
3. Pregnant women, lactating women or women of childbearing age who have birth requirements;
4. Mental patients, or cognitive dysfunction;
5. Participated in other clinical trials in the last 3 months;
6. Allergic persons, or those known to be allergic to therapeutic drugs;
7. It is expected that the compliance is poor and it is not possible to visit regularly;
8. Patients who do not have a current address or whose current address is incomplete and have no contact number;
9. The investigator believes that there are other situations that are not suitable for the trial.

Trial design

12,400 participants in 2 patient groups

Exposed group

Description:

Chinese patent medicine combined with western medicine routine

Treatment:

Drug: Chinese patent medicine

Non-exposed group

Description:

Western medicine routine treatment