Effectiveness and Safety of Tongxinshu Capsule in Treating Stable Angina Pectoris of Coronary Heart Disease with Qi Deficiency and Blood Stasis Syndrome

Phase 4

Recruiting

• Conditions: Coronary heart disease stable angina pectoris

• Registration Number: ITMCTR2100004438
• Lead Sponsor: Guang'anmen Hospital, China Academy of Chinese Medical Sciences

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) In line with the western medicine diagnostic criteria of coronary heart disease angina pectoris, angina more than 2 times per week attack I - III level in patients with angina pectoris;
2) TCM syndrome differentiation for qi deficiency and blood stasis;
3) Between the ages of 30 and 75, for both men and women;
4) Voluntary signing of informed consent.

Exclusion Criteria

1) Acute myocardial infarction, unstable angina, stable fatigue angina pectoris IV level and other heart diseases.
2) Combined with poorly controlled hypertension and diabetes mellitus, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), and with a history of heart pacemaker and cerebrovascular disease within 1 year.
3) Percutaneous coronary intervention or coronary artery bypass graft was performed in the last 3 months
4) History or evidence of any of the following diseases during the screening period:
Serious cardiovascular disease;
Active, recurrent peptic ulcer or other the risk of hemorrhagic disease;
Other digestive serious illness;
Merger malignant tumor, blood system diseases, serious or progressive disease, or other system;
Merging other patients with mental illness to cooperation or unwilling to cooperate.
5) Before screening, any of the laboratory examination indicators shall meet the following standards:
Hospital kidney function tip: ALT, AST > 1.5 times the upper limit of normal, Cr > 1.2 times the upper limit of normal (in reference to the research center laboratory normal range).
Other laboratory examination with clinical significance is unusual, and the researchers of decision should not be set.
6) Suspected or proven history of alcohol or drug abuse.
7) Pregnant or lactating women or those who have planned to have a recent pregnancy and are unwilling to use contraceptive methods.
8) Patients who had participated in clinical trials of other drugs within 3 months before enrollment.
9) The investigator believes that it is inappropriate for the patients to participate in this clinical trial and for other reasons such as non-compliance and poor compliance.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Seattle Angina Questionnaire, SAQ;

Secondary Outcome Measures

Name	Time	Method
Tumor necrosis factor - alpha;TCM syndrome score;Electrocardiogram;Minnesota Life Scale;Hypersensitive C-reactive protein (hs-CRP);Ultrasonic cardiogram;Interleukin-6;