Using Yiqilishui formula to treat heart dysfunction caused by sepsis

Double-blind Randomized Parallel Contrast Clinical Study of Yiqilishui Formula on Sepsis Induced Myocardial Dysfunction

This study is testing if a traditional Chinese medicine called Yiqilishui can help improve heart function in people with heart problems caused by sepsis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: Dongzhimen Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06686355 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are ICU patients aged 50 to 80 diagnosed with SIMD and exhibiting signs of Qi deficiency and water flooding syndrome.

Not a fit: Patients with acute coronary syndrome, structural heart abnormalities, or severe primary diseases affecting survival may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve heart function and reduce mortality in patients suffering from SIMD.

How similar studies have performed: While the use of traditional Chinese medicine in critical care is gaining interest, this specific approach with the Yiqilishui formula has not been extensively tested in similar studies.

Eligibility criteria

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 this trial is running

Beijing

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

Study contacts

• Study coordinator: Guoxia Zhang

Conditions Sepsis Induced Myocardial Dysfunction; sepsis; myocardial dysfunction; SIMD; Yiqilishui formula; Double-blind randomized; clinical study