The Treatment of Sepsis Induced Myocardial Dysfunction With Yiqilishui Formula

NCT06686355 | Recruiting Phase 2

• 1 other identifier: DongzhimenH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis Induced Myocardial Dysfunction

Keywords

sepsis; myocardial dysfunction; SIMD; Yiqilishui formula; Double-blind randomized; clinical study

Outcome Measures

Primary Outcomes (1)

• BNP（B-type natriuretic peptide） decline rate

  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.

  At enrollment, on the 3rd day, the 7th day, and the 14th day

Secondary Outcomes (19)

• The levels of cTnI

  At enrollment, on the 3rd day, the 7th day, and the 14th day

• The levels of CK-MB

  At enrollment, on the 3rd day, the 7th day, and the 14th day

• Concentration of H-FABP

  At enrollment, on the 3rd day, the 7th day, and the 14th day

• Tei index

  At enrollment, on the 3rd day, the 7th day, and the 14th day

• MEE

  At enrollment, on the 3rd day, the 7th day, and the 14th day

Other Outcomes (15)

• The level of body temperature

  Daily from enrollment to the 7th day.

• Breathing rate

  Daily from enrollment to the 7th day.

• Heart rate

  Daily from enrollment to the 7th day.

Study Arms (2)

Yiqilishui group

EXPERIMENTAL

Conventional Western medicine treatment + oral or nasogastric administration of Yiqilishui formula granules, twice daily;

Drug: Yiqilishui formula

placebo group

SHAM COMPARATOR

Conventional Western medicine treatment + oral or nasal feeding of Yiqilishui formula placebo , twice daily.

Other: Placebo

Interventions

Yiqilishui formula DRUG

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;

Yiqilishui group

Placebo OTHER

5% Yiqilishui Granules + 95% Dextrin;

placebo group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

Study Sites (1)

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Beijing, 100007, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Guoxia Zhang

CONTACT

+86-010-84013192; 2721064904@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Inclusion criteria: 1. Patients hospitalized in the ICU of Beijing Tongzhou Traditional Chinese Medicine Hospital and the ICU of Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine from January 2024 to December 2026. 2. Meeting the diagnostic criteria for Qi deficiency and water overflow syndrome of septic cardiomyopathy. 3. Age ≥50 and ≤85 years old; 4. SOFA score: 2 to 12 points; 5. Diagnosis of septic cardiomyopathy within 24 hours; 6. Patient or family member has signed the informed consent form.

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: November 13, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)