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A multicenter, open, randomized controlled clinical trial about DanHong injection, volume-effect relationship in patients with acute myocardial infarction

A multicenter, open, randomized controlled clinical trial about DanHong injection, volume-effect relationship in patients with acute myocardial infarction

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111341
Enrollment
Unknown
Registered
2025-10-29
Start date
2023-08-23
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

acute myocardial infarction

Interventions

??????:Danhong Injection 40ml+0.9% physiological saline 250ml intravenous infusion, once a day, for a course of one week
??????:Danhong injection 40ml+0.9% saline 250ml intravenous infusion, twice a day, for a course of one week

Sponsors

Beijing Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for acute myocardial infarction in the guidelines According to the Diagnosis and Treatment Guidelines for Acute ST Segment Elevation Myocardial Infarction (2019), Diagnosis and Treatment Guidelines for Non ST Segment Elevation Acute Coronary Syndrome (2016), and Professor Zhang Minzhou's Traditional Chinese Medicine Clinical Diagnosis and Treatment Guidelines for Acute Myocardial Infarction (hereinafter referred to as the Guidelines) jointly developed by the Chinese Cardiovascular Journal Editorial Committee of the Cardiovascular Disease Branch of the Chinese Medical Association Western medicine diagnosis: Elevated cardiac biomarker (preferred troponin cTn) with at least one value exceeding the 99th percentile of the reference value and accompanied by at least one of the following evidence of myocardial ischemia: 1) Symptoms of myocardial ischemia 2) New ST-T changes or new left bundle branch block (LBBB) 3) Pathological Q waves on electrocardiogram 4) Imaging evidence suggesting new local wall motion abnormalities or loss of surviving myocardium 5) Coronary angiography or autopsy confirming thrombus in the coronary artery 2. Consistent with the traditional Chinese medicine differentiation of blood stasis syndrome The diagnostic criteria for traditional Chinese medicine syndrome and blood stasis syndrome are as follows, based on the national standard of the People's Republic of China - TCM clinical diagnosis and treatment terminology syndrome section Main symptoms: 1 chest pain 2 chest tightness Secondary symptoms: 1. shortness of breath; 2. Exhausted and weak; 3. Purple and dark complexion; Tongue pulse: The tongue is light purple and the pulse is astringent. Diagnostic criteria: Diagnosis can be made by having one of the two main symptoms, chest pain and tightness, and two other secondary symptoms, as well as supporting tongue and pulse. 3. Age between 18-75 years old (including 18 and 75 years old), gender is not limited; 4. Subject informed consent and signing of informed consent form;

Exclusion criteria

Exclusion criteria: 1. Within 6 months, there has been a cerebrovascular accident or transient ischemic attack; Large artery aneurysm or aortic dissection; Pulmonary embolism; 2. Combined severe liver and kidney dysfunction (alanine aminotransferase>1.5 times the upper limit of normal, creatinine>1.5 times the upper limit of normal); 3. Patients with severe primary diseases such as hematopoietic system, malignant tumors, and mental illness; 4. Individuals with a history of alcohol or drug abuse within the past year; 5. Individuals with allergic constitution or allergies to the ingredients of this medicine; 6. Pregnant or lactating women; 7. Participants in other clinical trials within the past 3 months; 8. Researchers believe that there may be serious complications and comorbidities that are not suitable for participants in clinical trials;

Design outcomes

Primary

MeasureTime frame
LVEF;Traditional Chinese medicine syndrome;

Secondary

MeasureTime frame
cTnI cTnT CK CK-MB;

Countries

China

Contacts

Public ContactLiuHongxu

Beijing Hospital of Traditional Chinese Medicine

lhx_@263.net+86 135 0116 1583

Outcome results

None listed

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