The Treatment of Sepsis Induced Myocardial Dysfunction With Yiqilishui Formula

Official title

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

Overview

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.

Detailed description

Sepsis-induced myocardial dysfunction (SIMD) is characterized by high morbidity and mortality rates and remains a challenging issue in the field of critical care that has not yet been resolved. The main pathogenesis involves deficiency of Qi with water overflow and blood stasis and toxin blocking the channels. The use of a Qi-invigorating and diuretic formula has the effect of invigorating Qi, promoting diuresis, and detoxifying and unblocking the channels. This study employed a two-center prospective parallel randomized double-blind controlled trial, selecting a total of 80 SIMD subjects from the ICU of Tongzhou District Traditional Chinese Medicine Hospital and the ICU of Dongzhimen Hospital of Beijing University of Chinese Medicine, who met the inclusion and exclusion criteria. The subjects were randomly and evenly divided into a treatment group and a control group. Both groups received basic SIMD treatment, with the treatment group additionally receiving the oral or nasogastric administration of a granule preparation of Yiqilishui formula, and the control group receiving a placebo orally or nasogastrically. The intervention period was 7 days, with a follow-up period of 28 days. The primary efficacy indicators compared between the two groups were BNP and NT-proBNP, and the secondary efficacy indicators were echocardiography, myocardial injury markers, inflammatory markers, critical illness severity scores, ICU length of stay and costs, and 28-day survival rate. The study aimed to evaluate the clinical efficacy and safety of the Yiqilishui formula for SIMD.

Interventions

• Drug 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;
• Other Placebo
  5% Yiqilishui Granules + 95% Dextrin;

Primary outcome measures

• BNP（B-type natriuretic peptide） decline rate [Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day]

Secondary outcome measures (12)

• The levels of cTnI [Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day]
• The levels of CK-MB [Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day]
• Concentration of H-FABP [Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day]
• Tei index [Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day]
• MEE [Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day]
• LVMI [Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day]
• The levels of WBC [Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day]
• The percentage of NE% [Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day]
• The levels of CRP [Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day]
• The levels of PCT [Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day]
• Concentration of IL-6 [Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day]
• Concentration of TNF-α [Time frame: At enrollment, on the 3rd day, the 7th day, and the 14th day]

Eligibility criteria

Inclusion criteria

• 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.
• Patients diagnosed with SIMD and qi deficiency and water flooding syndrome.
• Aged 50 to 85 years.
• SOFA score: 2 to 12 points.
• Diagnosis of SIMD within 24 hours.
• Signed informed consent by the patient or their family.

Exclusion criteria

• Subjects diagnosed with acute coronary syndrome.
• Subjects with heart failure caused by cardiomyopathies such as hypertrophic cardiomyopathy, dilated cardiomyopathy, myocardial amyloidosis, diabetic cardiomyopathy, or hypothyroid cardiomyopathy.
• Subjects with heart failure caused by structural heart abnormalities, arrhythmias, pulmonary heart disease, or cardiorenal syndrome.
• Subjects with severe primary diseases affecting survival, including uncontrolled, unresectable metastatic malignant tumors, hematologic diseases, and HIV.
• Subjects with liver or kidney dysfunction, with an individual SOFA score of ≥3 for liver or kidney function.
• Subjects who have used immunosuppressants continuously in the last 6 months or have undergone organ transplantation.
• Subjects who have used corticosteroids (equivalent to methylprednisolone ≥20mg/day) continuously within 7 days prior to enrollment.
• 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.
• Subjects deemed unable to take decoctions by clinicians.
• Pregnant or breastfeeding women.
• Subjects who have participated in other clinical trials within the last 30 days.
• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine — Beijing

Identifiers

NCT: NCT06686355 · DongzhimenH

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗