The Treatment of Sepsis Induced Myocardial Dysfunction With Yiqilishui Formula
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-85
SponsorDongzhimen Hospital, Beijing
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Yiqilishui formula
DrugAstragalus 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
Other intervention5% Yiqilishui Granules + 95% Dextrin;
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Yiqilishui groupExperimental treatment 1 intervention
Group B: placebo groupSham comparator 1 intervention
Trial outcomes
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.
Time frame
At enrollment, on the 3rd day, the 7th day, and the 14th daySecondary outcomes
1
The levels of cTnI
Cardiac injury markers-Blood samples from the median cubital vein of the subjects were taken at enrollment, on the 3rd day, the 7th day, and the 14th day to detect the levels of cardiac troponin I (cTnI)
Time frame
At enrollment, on the 3rd day, the 7th day, and the 14th day2
The levels of CK-MB
Cardiac injury markers-Blood samples from the median cubital vein of the subjects were taken at enrollment, on the 3rd day, the 7th day, and the 14th day to detect the levels of creatine kinase MB isoenzyme
Time frame
At enrollment, on the 3rd day, the 7th day, and the 14th day3
Concentration of H-FABP
Cardiac injury markers-Blood samples from the median cubital vein of the subjects were taken at enrollment, on the 3rd day, the 7th day, and the 14th day to detect the levels of heart-type fatty acid-binding protein
Time frame
At enrollment, on the 3rd day, the 7th day, and the 14th day4
Tei index
At the time of subject enrollment, on the 3rd day, 7th day, and 14th day, Tei index were measured using transthoracic echocardiography to evaluate the subjects' cardiac function and structure.
Time frame
At enrollment, on the 3rd day, the 7th day, and the 14th dayOther outcomes
1
The level of body temperature
During the intervention period, record the patient's underarm temperature measurement daily.
Time frame
Daily from enrollment to the 7th day.2
Breathing rate
During the intervention period, record the patient's breathing rate measurement daily.
Time frame
Daily from enrollment to the 7th day.3
Heart rate
During the intervention period, record the patient's heart rate measurement daily.
Time frame
Daily from enrollment to the 7th day.4
The levels of blood pressure
During the intervention period, record the patient's blood pressure measurement daily.
Time frame
Daily from enrollment to the 7th day.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov