A randomized, double-blind, placebo parallel controlled clinical trial of Bushen Huoxue Decoction for treatment of coronary heart disease with kidney deficiency and blood stasis syndrome

Not Applicable

• Conditions: Coronary heart disease

• Registration Number: ITMCTR2000003557
• 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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Follow the diagnostic criteria for unstable angina pectoris of coronary heart disease;
2. Patients who diagnosed with kidney deficiency and blood stasis syndrome by TCM syndromes;
3. Patients aged between 18 and 80 years;
4. Patients who voluntarily sign the informed consent.

Exclusion Criteria

1. Severe valvular heart disease, severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, biliary heart disease, stomach and esophageal reflux and other non-coronary heart disease caused by chest pain;
2. Poor hypertension control (under drug control, blood pressure >=160/100mmHg at rest and occasionally within a week), severe cardiopulmonary insufficiency (EF<35%), severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia,atrioventricular block of type II and above, complete bundle branch block);
3. Complicated with serious primary diseases such as heart, brain, liver, kidney, hematopoietic system, (hepatic function ALT or AST value ?1.5 times the upper limit of normal, patients with abnormal renal function), insulin-dependent type 2 diabetes;
4. Patients with depression or anxiety;
5.Pregnant or lactating women;
6. Patients with malignant tumors;
7. Patients with allergies and allergies to test drug components;
8. Patients with poor compliance and low possibility of follow-up;
9. Participants in other clinical trials within the past month;
10. Other major diseases or factors that interfere with the completion of the trial or affect the interpretation of the results.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
The effect of TCM Syndromes of coronary heart disease and angina pectoris;The effect of coronary heart disease and angina pectoris;

Secondary Outcome Measures

Name	Time	Method
Seattle Angina Questionnaiire;Safety evaluation;Cardiovascular endpoint;Blood lipid efficacy;ECG efficacy;Stop and decrease of nitroglycerin;