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Comparative study on clinical efficacy and safety of traditional decoction and formula granules of Buyang Huanwu decoction in the treatment of acute myocardial infarction with Qi deficiency and blood stasis syndrome after PCI

Comparative study on clinical efficacy and safety of traditional decoction and formula granules of Buyang Huanwu decoction in the treatment of acute myocardial infarction with Qi deficiency and blood stasis syndrome after PCI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000633
Enrollment
Unknown
Registered
2024-11-01
Start date
2024-11-15
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

acute myocardial infarction

Interventions

decoction group:Standard treatment with western medicine+traditional decoction of Buyang Huanwu
granule group:Standard treatment with western medicine+formula granules of Buyang Huanwu decoction
blank control group:Standard treatment with western medicine

Sponsors

Nanfang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1: Age between 18-75 years old, male or female. 2: Acute infarction diagnosed by western medicine, with onset <12h and successful PCI at the same time 3: Cardiac function Killip class ? ~ ? 4: Acute ST-segment elevation myocardial infarction patients with TIMI score = 3, acute non-ST-segment elevation myocardial infarction patients with TIMI score = 2. 5: Traditional Chinese Medicine (TCM) diagnosis of qi deficiency and blood stasis 6: Informed consent, voluntary

Exclusion criteria

Exclusion criteria: 1: Non-acute myocardial infarction or acute myocardial infarction onset >12h history of previous PCI 2: Killip Classification III and above 3: TIMI score >3 in patients with acute ST-segment elevation myocardial infarction and >2 in patients with acute non-ST-segment elevation myocardial infarction 4: Those with ventricular septal perforation suspected aortic coarctation 5: Combined with severe cardiopulmonary insufficiency severe arrhythmia 6: Patients with severe primary diseases such as liver kidney hematopoietic system and psychiatric disorders 7: Comorbidities with peripheral vascular disease embolic disease stroke hyperthermia infections or autoimmune diseases 8: Pregnant or lactating women allergic individuals participants in clinical trials of other drugs poor compliance low likelihood of follow up

Design outcomes

Primary

MeasureTime frame
Changes in left ventricular ejection fraction;

Secondary

MeasureTime frame
Left end-systolic ventricular internal diameter ;left end-diastolic left ventricular posterior wall thickness;left end-diastolic internal diameter;Major adverse cardiovascular events (all-cause mortality nonfatal myocardial infarction recurrent revascularization of the target vessel and in-stent thrombosis within 3 months of the procedure);left end-diastolic volume;left end-systolic left ventricular posterior wall thickness;left end-systolic volume;Changes of TCM Syndrome Score;Killip classification;Quality of Survival Assessment;

Countries

China

Contacts

Public ContactChen Yanmei

Nanfang Hospital of Southern Medical University

yanmei0812@smu.edu.cn13631367152

Outcome results

None listed

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