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The Clinical Efficacy Evaluation Study of "Wenshen Yangxin Granules" in the Treatment of Septic Myocarditis (SIC)

The Clinical Efficacy Evaluation Study of "Wenshen Yangxin Granules" in the Treatment of Septic Myocarditis (SIC)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077549
Enrollment
Unknown
Registered
2023-11-13
Start date
2023-12-25
Completion date
Unknown
Last updated
2024-03-11

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

Conditions

Sepsis-induced Cardiomyopathy

Interventions

Treatment group:Wenshen Yangxin Granules
Placebo group:placebo

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Signing the informed consent form; (2) Meeting the diagnostic criteria for SIC; (3) Age between 18 and 80 years; (4) Patients admitted to the intensive care unit with an anticipated hospital stay of =7 days.

Exclusion criteria

Exclusion criteria: (1) Patients expected to die within 24 hours; (2) History of acute coronary syndrome, acute myocardial infarction diagnosis, or chronic heart failure; (3) Concomitant severe cardiac conditions such as valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, etc.; (4) Postoperative patients after cardiac surgery in the last 2 months; (5) Suffering from severe primary diseases, including inoperable tumors, blood system disorders, and HIV infection; (6) Severe liver or kidney dysfunction (defined as liver or kidney component of SOFA score =3); (7) Received immunosuppressive agents or organ transplantation within the last 6 months; (8) Patients with allergies or hypersensitivity to Chinese herbal decoctions; (9) Pregnant or lactating women; (10) Participants in other clinical trials within the past 3 months; (11) Patients with contraindications to herbal decoction; (12) Other conditions considered inappropriate for participation by the clinical investigator.

Design outcomes

Primary

MeasureTime frame
all-cause mortality 28 days;28-day cardiac mortality;hospital mortality;

Secondary

MeasureTime frame
ICU mortality;ICU length of stay;hospital length of stay;change in Acute Physiology and Chronic Health Evaluation (APACHE) II score;change in the SOFA score;Echocardiogram;biomarker;hemodynamic parameters;central venous oxygen saturation;plasma lactate concentration;inflammatory markers;Utilization and Duration of Mechanical Circulatory Support;mechanical ventilation duration;CRRT usage;administration of vasopressors;administration of positive inotropic agents;Kansas City Cardiomyopathy Questionnaire (KCCQ-23) score;

Countries

China

Contacts

Public ContactPeiyang Gao

Hospital of Chengdu University of Traditional Chinese Medicine

gaopy930@126.com+86 189 8002 5566

Outcome results

None listed

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