Using Yiqilishui formula to treat heart dysfunction caused by sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of the Yiqilishui formula, a traditional Chinese medicine, in treating sepsis-induced myocardial dysfunction (SIMD). Participants will receive either the Yiqilishui formula or a placebo alongside standard Western treatment for a duration of 7 days. The study will assess heart function improvements and safety through various medical evaluations, including blood tests and echocardiograms, over a follow-up period of 28 days. The trial is designed as a double-blind, randomized controlled trial involving two hospitals in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Patients hospitalized in the ICU of Tongzhou Traditional Chinese Medicine Hospital and Dongzhimen Hospital of Beijing University of Chinese Medicine between January 2024 and December 2026.
2. Patients diagnosed with SIMD and qi deficiency and water flooding syndrome.
3. Aged 50 to 85 years.
4. SOFA score: 2 to 12 points.
5. Diagnosis of SIMD within 24 hours.
6. Signed informed consent by the patient or their family.

Exclusion Criteria

1. Subjects diagnosed with acute coronary syndrome.
2. Subjects with heart failure caused by cardiomyopathies such as hypertrophic cardiomyopathy, dilated cardiomyopathy, myocardial amyloidosis, diabetic cardiomyopathy, or hypothyroid cardiomyopathy.
3. Subjects with heart failure caused by structural heart abnormalities, arrhythmias, pulmonary heart disease, or cardiorenal syndrome.
4. Subjects with severe primary diseases affecting survival, including uncontrolled, unresectable metastatic malignant tumors, hematologic diseases, and HIV.
5. Subjects with liver or kidney dysfunction, with an individual SOFA score of ≥3 for liver or kidney function.
6. Subjects who have used immunosuppressants continuously in the last 6 months or have undergone organ transplantation.
7. Subjects who have used corticosteroids (equivalent to methylprednisolone ≥20mg/day) continuously within 7 days prior to enrollment.
8. Subjects who have used Chinese herbal medicines or Chinese patent medicine replenishing qi, activating blood circulation and facilitating diuresis within 14 days prior to enrollment.
9. Subjects deemed unable to take decoctions by clinicians.
10. Pregnant or breastfeeding women.
11. Subjects who have participated in other clinical trials within the last 30 days.
12. Subjects deemed unable to complete or unsuitable for this study by the researchers (e.g., expected death within 48 hours or refusal of active treatment).

Where it's running

• Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
  Beijing, China Recruiting

Study contacts

• Study coordinator: Guoxia Zhang
• Email: 2721064904@qq.com
• Phone: +86-010-84013192

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.