Dazhu Hongjingtian injection as adjuvant therapy for improved assessment of patients with stable angina (SA) and unstable angina (UA)

Phase 4

• Conditions: Stable Angina and Unstable Angina

• Registration Number: ITMCTR2022000006
• Lead Sponsor: Institute Of Basic Research In Clinical Medicine,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. Age = 18 years, including male and female subjects;
2. Inpatients who meet the diagnostic criteria of Western medicine for stable angina (SA) and unstable angina (UA);
3. The frequency of angina pectoris = 2 times a week;
4. The patient, the patient's guardian, or the patient's family member signed the informed consent.

Exclusion Criteria

1. Patients diagnosed with hemorrhagic stroke;
2. Recent major surgery history or comorbidities such as malignant tumors, serious dysfunction of cardiovascular, cerebrovascular, liver, kidney, hematopoietic system
3. Cognitive impairment, mental or neurological abnormalities that make unable to complete the questionnaire
4. Comorbidities with severe heart disease (heart function class III or IV), malignant hypertension (systolic blood pressure = 160 mm Hg or diastolic blood pressure = 100 mm Hg), severe heart failure (NYHA heart failure class IV), severe arrhythmia, PCI treatment within 3 months, use of a pacemaker, acute myocardial infarction, old myocardial infarction, pulmonary embolism, cardiomyopathy, aortic valve stenosis, and other heart valve diseases;
5. Situations that affect ST-T changes in ECG, such as myocardial hypertrophy, left bundle branch block, digitalis drug influence, electrolyte disturbance, etc.;
6. Chest pain caused by lesions other than coronary artery disease, such as psychosis, severe neurosis, hyperthyroidism, biliary heart syndrome, gastroesophageal reflux, aortic dissection, etc.;
7. Comorbidities such as severe hepatic and renal insufficiency (including dialysis treatment), active liver disease (including primary biliary cirrhosis and unexplained persistent hepatic insufficiency), alanine aminotransferase (ALT), Aspartate aminotransferase (AST) > 1.5 times the upper limit of normal, creatinine (Cr) clearance > 1.5 times the upper limit of normal, or total bilirubin (TBIL) = 2 times the upper limit of normal;
8. People with contraindications stated in the instructions of Dazhu Hongjingtian injection (pregnant women, allergic constitution, previous allergic to multiple drugs, allergic to the ingredients in the research drug, or a history of adverse reactions with Dazhu Hongjingtian preparation);
9. Control group who used Dazhu Hongjingtian (tablets, capsules, etc.) or other traditional Chinese medicine preparations for promoting blood circulation and removing blood stasis;
10. Patients who are considered inappropriate by other researchers to participate in this study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
umber of angina attacks before discharge (times/week);30-day incidence of adverse cardiovascular and cerebrovascular events (all-cause death, heart failure, stroke, myocardial infarction);

Secondary Outcome Measures

Name	Time	Method
Changes in the grade of angina pectoris;Evaluation of the curative effect of blood stasis syndrome ;Quality of life;Incidence of adverse events;Nitrates usage before discharge (tablets/week);ECG, laboratory test indicators, physical indicatorschanges;