Actively Recruiting
The Treatment of Sepsis Induced Myocardial Dysfunction With Yiqilishui Formula
Led by Dongzhimen Hospital, Beijing · Updated on 2026-03-30
80
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if Chinese medicine - Yiqilishui formula works to treat sepsis-induced myocardial dysfunction (SIMD). It will also learn about the safety of Yiqilishui formula. The main questions it aims to answer are: * Compared with conventional western traetment alone, can supplementing conventional Western treatment with Yiqilishui formula better improve the heart function and reduce mortality of participants with SIMD? * What medical problems do participants have when taking Yiqilishui formula? Researchers will compare Yiqilishui formula to a placebo (a look-alike substance that contains no drug) to see if Yiqilishui formula works to treat SIMD. Participants will: * Take Yiqilishui formula granules or placebo twice daily for 7 days, while receiving standard conventional Western treatment. * Undergo blood drawing, electrocardiogram and transthoracic echocardiography at enrollment, on the 3rd day, the 7th day, and the 14th day after enrollment.
CONDITIONS
Official Title
The Treatment of Sepsis Induced Myocardial Dysfunction With Yiqilishui Formula
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients hospitalized in the ICU of Tongzhou Traditional Chinese Medicine Hospital or Dongzhimen Hospital of Beijing University of Chinese Medicine between January 2024 and December 2026
- Diagnosed with sepsis-induced myocardial dysfunction and qi deficiency with water flooding syndrome
- Aged 50 to 85 years
- SOFA score between 2 and 12 points
- Diagnosis of sepsis-induced myocardial dysfunction within 24 hours
- Signed informed consent by the patient or their family
You will not qualify if you...
- Diagnosed with acute coronary syndrome
- Heart failure caused by cardiomyopathies such as hypertrophic cardiomyopathy, dilated cardiomyopathy, myocardial amyloidosis, diabetic cardiomyopathy, or hypothyroid cardiomyopathy
- Heart failure caused by structural heart abnormalities, arrhythmias, pulmonary heart disease, or cardiorenal syndrome
- Severe primary diseases affecting survival, including uncontrolled metastatic malignant tumors, hematologic diseases, and HIV
- Liver or kidney dysfunction with an individual SOFA score of 3 or higher for liver or kidney function
- Use of immunosuppressants continuously in the last 6 months or organ transplantation
- Use of corticosteroids equivalent to methylprednisolone 20mg/day continuously within 7 days before enrollment
- Use of Chinese herbal medicines or Chinese patent medicines that replenish qi, activate blood circulation, or facilitate diuresis within 14 days before enrollment
- Unable to take decoctions as judged by clinicians
- Pregnant or breastfeeding
- Participation in other clinical trials within the last 30 days
- Deemed unable to complete or unsuitable for the study by researchers, including expected death within 48 hours or refusal of active treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, China, 100007
Actively Recruiting
Research Team
G
Guoxia Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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