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

Atherosclerotic Heart Disease With Angina Nos Clinical Trial

— CSCD-TCM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04022031
• Other study ID #: CSCD-TCM
• Status: Not yet recruiting
• Start date: September 1, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: July 2019
• Source: Tianjin University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12400
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2021
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Atherosclerotic Heart Disease With Angina Nos
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Chinese patent medicine
Shexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill.

Locations

Country	Name	City	State
China	Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cardiovascular events	These include acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG).	one year
Secondary	Death from all causes		one year
Secondary	Re-admission due to cardiovascular events		one year
Secondary	Seattle Angina Questionnaire		three months
Secondary	Clinical biochemical test		three months
Secondary	Film degree exam		three months