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The effect and mechanism of Xidan granules on cardiac function and quality of life in patients with acute myocardial infarction after PCI

The effect and mechanism of Xidan granules on cardiac function and quality of life in patients with acute myocardial infarction after PCI

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085936
Enrollment
Unknown
Registered
2024-06-21
Start date
2024-06-30
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Cardiovascular disease

Interventions

Treatment group:Treatment group: Xidan granules+Western medicine basic treatment Chinese medicine prescription name: Xidan granules Drug composition: 10g of American ginseng and 30g of Salvia miltiorr
control group:Control group: placebo granules+Western medicine basic treatment Placebo granules: mainly composed of dextrin+5% traditional Chinese medicine, with the same appearance and odor as Xidan

Sponsors

Dongfang Hospital of Beijing University 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; (2) Confirmed by coronary angiography and treated with PCI within 24 hours; (3) Patients with TCM syndrome types of Qi deficiency and blood stasis; (4) Age range from 18 to 75 years old; (5) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Acute complications of PCI (cardiac shock, ventricular fibrillation and other malignant arrhythmias after cardiopulmonary resuscitation, valve prolapse caused by chordae/papillary muscle rupture, heart rupture, coronary perforation, pericardial tamponade, as well as sustained IABP assistance for cardiogenic shock, sustained pacemaker assistance for severe bradycardia, and sustained heart failure that cannot be relieved by medication); (2) The patient's blood pressure is difficult to control, with systolic blood pressure = 180mmHg or diastolic blood pressure = 110mmHg; (3) Patients with severe liver and kidney dysfunction (alanine aminotransferase = 1.5 times the normal value, serum creatinine = 194.5 µ mol/L), serum potassium level = 5.5 mmol/L, or with severe endocrine diseases (such as hyperthyroidism, hypothyroidism, diabetes with severe complications); (4) Patients with severe consumption status, primary diseases of the blood system, malignant tumors, etc; (5) Newly diagnosed intracerebral hemorrhage patients within 6 months; (6) The patient has experienced a new bleeding event or trauma within the past month, or is currently suffering from a confirmed active gastrointestinal ulcer disease; (7) Suspicious or clear allergy to the investigational drug; (8) The patient is in pregnancy or lactation, or there may be a pregnancy planner during the follow-up period of this study; (9) Patients with mental illness or infectious diseases; (10) Participants in other clinical studies within the past month; (11) Traditional Chinese medicine syndrome differentiation combined with deficiency cold syndrome or excess cold syndrome.

Design outcomes

Primary

MeasureTime frame
Left ventricular systolic function change rate (? LVEF);

Secondary

MeasureTime frame
Cardiac ultrasound related indicators;Related indicators of angina pectoris;Traditional Chinese Medicine Syndrome Points and Therapeutic Effects;Quality of life indicators;Serological indicators;

Countries

the People's Republic of China

Contacts

Public ContactQuan Lin

Dongfang Hospital of Beijing University of Traditional Chinese Medicine

linquanys@163.com+86 130 7118 2139

Outcome results

None listed

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