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A randomized, double-blind, placebo-controlled, multicenter clinical trial for the effectiveness and safety of Shuxuening injection in the treatment of unstable angina

A randomized, double-blind, placebo-controlled, multicenter clinical trial for the effectiveness and safety of Shuxuening injection in the treatment of unstable angina

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019754
Enrollment
Unknown
Registered
2018-11-26
Start date
2018-11-30
Completion date
Unknown
Last updated
2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unstable angina

Interventions

Control group :Placebo(Sterile Water for Injection)+basic treatmen

Sponsors

Dongfang Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Signed informed consent; 2. Those who meet the diagnostic criteria for coronary heart disease(with any of the following) (1) History diagnosis of chronic myocardial infarction; (2) Previous positive exercise tablets(male patients); (3) Previous positive coronary angiography (narrowing of coronary artery diameter greater than or equal to 50%); (4) CTA ??4)CTA positive; 3. Patient in line with diagnostic criteria for UA; 4. At least once during the 48 hours before enrollment; 5. Patients with moderate or low risk of GRACE score <140; 6. Aged 30-75 years.

Exclusion criteria

Exclusion criteria: 1. Patients with stable angina pectoris and other serious heart diseases such as those with LVEF<40%, had severe heart rhythm disorders (such as rapid atrial fibrillation and flutter, paroxysmal ventricular tachycardia, II degree II type and III degree atrioventricular block), etc.; 2. Other factors affecting the total load evaluation of total ischemia burden, such as cardiac hypertrophy; left bundle branch block, and effect of the yankees' Digitalis drugs, eletrolyte disturbance, etc.; 3. Percutaneous coronary intervention or coronary artery bypass graft was performed within 1 month befor enrollment; 4. Had myocardial infarction one month before enrollment; 5. Chest pain caused by diseased other than coronary artery disease, such as psychosis, severe neurosis, hyperthyroidism, billary syndrome, gastroesophageal reflux, aortic dissection,ect. 6. Having a history of bleeding or taking anti-coagulant drugs such as warfarin; 7. Combined liver and kidney and hematopoietic system and other serious diseases, liver function (ALT, AST) 1.5 times higher than the upper limit of normal renal function, serum creatinine (SCR) was 1.2 times the normal upper limit; 8. Severe respiratory diseases, such as respiratory failure; 9. Pregnant or preparing for pregnancy lactating women; 10. Allergy to any ingredients of the test herbs in this trial; 11. Involved in other clinical trial in 1 month.

Design outcomes

Primary

MeasureTime frame
Improvement in the number of angina attacks (comparison among groups before and after treatment);

Secondary

MeasureTime frame
The change of total ischemia burden (24-hour Holter ECG) before and after treatment;Improvement in the number of angina attacks (comparison among groups before and after treatment, comparison among groups during follow-up);Improvement of angina duration within 3, 10, 30 days after treatment;Improvement of VAS within 3, 10, 30 days after treatment;The nitroglycerin reducing or stopping rate within 3, 10, 30 days after treatment;Incidence (including revascularization and fatal myocardial infarction, nonfatal myocardial infarction, sudden cardiac death) of MCE within 3, 10, 30 days after treatment;The change of symptom of angina pectoris scale score within 3, 10, 30 days after treatment;Distribution of GRACE score within 10 days after treatment;

Countries

China

Contacts

Public ContactQian Lin

Dongfang Hospital, Beijing University of Chinese Medicine

13910565673@126.com+86 13910565673

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026