The Treatment of Sepsis Induced Myocardial Dysfunction With Yiqilishui Formula

NCT06686355 · tracked via the Priya Life Science China tracker

Sponsor

Dongzhimen Hospital, Beijing

Phase

Phase 2

Started

2024-11-20

Last updated

2026-03-30

Condition(s) studied

Sepsis Induced Myocardial Dysfunction

Investigational drug(s) / intervention(s)

Yiqilishui formulaPlacebo

Yiqilishui formula: Astragalus Root 30g, Angelica sinensis 30g, Honeysuckle Flower 30g, Capillary Artemisia Herb 15g, Giant Knotweed Rhizome 15g, Lepidium Seed 30g, Sichuan Lovage Rhizome 15g, Salvia Root 15g, Jujube Fruit 15g;

Placebo: 5% Yiqilishui Granules + 95% Dextrin;

Study summary

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.

Eligibility

Sex

ALL

Min age

50 Years

Max age

85 Years

Healthy volunteers

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).

Primary outcome measure(s)

BNP（B-type natriuretic peptide） decline rate — At enrollment, on the 3rd day, the 7th day, and the 14th day
Blood samples were taken from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day to measure the BNP levels in the subjects' venous blood, calculate the patient's BNP decline rate, assess the severity of heart failure in the subjects, and predict their prognosis.

Trial sites (1)

Facility	City	Region	Status
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine	Beijing	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06686355 on ClinicalTrials.gov ↗ ← All trials in China