NCT04026724

Brief Summary

A retrospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.The hospital's medical record management system was used to collect symptoms of angina pectoris, dose and frequency of nitroglycerin use, clinical biochemical test and imaging examination.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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

July 13, 2019

Last Update Submit

July 18, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Symptoms of angina

    one year

  • Dosage and frequency of use of nitroglycerin

    one year

  • Clinical biochemical indicators test

    one year

  • Film degree exam

    one year

Study Arms (2)

Exposed group

Chinese patent medicine combined with western medicine routine treatment

Drug: Chinese patent medicine

Non-exposed group

Western medicine routine treatment

Interventions

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

Exposed group

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The collaboration network of coronary heart disease research medical units formed by the research group, including the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Nankai Hospital, Tianjin Chest Hospital, Tianjin Medical University General Hospital, a total of 5 hospitals.

You may qualify if:

  • Age 35-75 years old, gender is not limited;
  • Admission time is September 1, 2014 - September 1, 1919;
  • 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;
  • 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.

You may not qualify if:

  • 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;
  • patients with acute myocardial infarction, heart failure, myocarditis, cardiomyopathy, severe heart valve disease, liver failure or renal failure, malignant tumors and severe metabolic diseases, as well as patients with severe symptoms and uncontrollable angina;
  • Pregnant women, lactating women or women of childbearing age who have birth requirements;
  • Mental patients, or cognitive dysfunction;
  • The investigator believes that there are other situations that are not suitable for the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300193, China

Location

Related Publications (4)

  • Lai Z, Liu Y, Huang M, Li L, Li Z, Su J, Pan G, Li B, Gao S, Yu C. Associations Between Atherosclerosis and Elevated Serum Alkaline Phosphatase in Patients With Coronary Artery Disease in an Inflammatory State. Heart Lung Circ. 2023 Sep;32(9):1096-1106. doi: 10.1016/j.hlc.2023.05.012. Epub 2023 Aug 5.

  • Wang J, Huang X, Fu C, Sheng Q, Liu P. Association between triglyceride glucose index, coronary artery calcification and multivessel coronary disease in Chinese patients with acute coronary syndrome. Cardiovasc Diabetol. 2022 Sep 16;21(1):187. doi: 10.1186/s12933-022-01615-4.

  • Yu L, Li Z, Yang R, Pan G, Cheng Q, He Y, Liu Y, Liu F, Ma M, Yang T, Wang Y, Su J, Zheng Y, Gao S, Xu Q, Li L, Yu C. Impaired Sensitivity to Thyroid Hormones Is Associated With Elevated Blood Glucose in Coronary Heart Disease. Front Endocrinol (Lausanne). 2022 Jun 15;13:895843. doi: 10.3389/fendo.2022.895843. eCollection 2022.

  • Su J, Li Z, Huang M, Wang Y, Yang T, Ma M, Ni T, Pan G, Lai Z, Li C, Li L, Yu C. Triglyceride glucose index for the detection of the severity of coronary artery disease in different glucose metabolic states in patients with coronary heart disease: a RCSCD-TCM study in China. Cardiovasc Diabetol. 2022 Jun 6;21(1):96. doi: 10.1186/s12933-022-01523-7.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 13, 2019

First Posted

July 19, 2019

Study Start

September 1, 2019

Primary Completion

March 1, 2020

Study Completion

September 1, 2020

Last Updated

July 22, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

Locations