Evidence-based Optimization Study for TCM Syndrome Differentiation and Treatment Protocol of Stable Angina

Not Applicable

Recruiting

• Conditions: Stable angina pectoris of coronary heart disease

• Registration Number: ITMCTR1900002386
• Lead Sponsor: iao'ning University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the diagnostic criteria of Western medicine 2.4(2) Diagnostic criteria for stable angina, Diagnostic criteria for chest bi-syndrome with the syndrome of turbid phlegm and blood stasis and have no conflict with the efficacy of Danlou tablets;
2. Aged from 35-75 years old;
3. Those who have not taken any TCM preparation within two weeks;
4. Those who can provide personal contact information and cooperate with the clinical trial visit and follow-up;
5. Those who voluntarily participate in clinical observations and sign informed consent form.

Exclusion Criteria

1. Stable angina complicated with valvular heart disease, various types of cardiomyopathy, malignant arrhythmia; The patients with heart failure whose NYHA cardiac function grading is III-IV;
2. Stable angina complicated with hypertension without treatment or uncontrolled hypertension (Bp=180/110mmHg);
3. Stable angina complicated with severe cerebrovascular disease;
4. Stable angina complicated with severe pulmonary insufficiency (PaO2<60mmHg), endocrine and hematopoietic systems severe primary disease, Moderate to severe hepatic insufficiency(Transaminase levels are 3 times higher than the upper limit of normal) or Moderate to severe renal insufficiency(eGFR<60ml/min/1.73m2) or patients with newly diagnosed acute;
5. Stable angina complicated with cerebrovascular disease during the past 3 months;
6. Stable angina complicated with psychosis;
7. Stable angina patient who are in the period of gestation or lactation;
8. Stable angina patient participated in other clinical trials in the past 3 months;
9. Patient with a life expectancy lower than 1 year;
10. Allergic patients or patients who are allergic to TCM treatment;
11. Those who are unwilling or unable to accept clinical follow-up.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of angina pectoris;

Secondary Outcome Measures

Name	Time	Method
Electrocardiogram;Serum differential endogenous products;MMP-9;Hemorheology;Echocardiography;Ang I;Exercise test;Seattle Angina Questionnaire;MPO;VCAM-1;IL-6;Hcy;Score of TCM symptoms;Anginal frequency;Blood glucose;Hs-CRP;Blood fat;Four coagulation;