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Clinical Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine

Prospective Cohort Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04022031
Acronym
CSCD-TCM
Enrollment
12400
Registered
2019-07-16
Start date
2019-09-01
Completion date
2022-09-01
Last updated
2019-07-17

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

Conditions

Atherosclerotic Heart Disease With Angina Nos

Brief summary

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.

Interventions

Shexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill.

Sponsors

Tianjin University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of cardiovascular eventsone yearThese include acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG).

Secondary

MeasureTime frame
Death from all causesone year
Re-admission due to cardiovascular eventsone year
Seattle Angina Questionnairethree months
Clinical biochemical testthree months
Film degree examthree months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026