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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yiqilishui group | Experimental | Conventional Western medicine treatment + oral or nasogastric administration of Yiqilishui formula granules, twice daily; |
|
| placebo group | Sham Comparator | Conventional Western medicine treatment + oral or nasal feeding of Yiqilishui formula placebo , twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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; |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | At enrollment, on the 3rd day, the 7th day, and the 14th day |
| The levels of CK-MB |
| Measure | Description | Time Frame |
|---|---|---|
| The level of body temperature | During the intervention period, record the patient's underarm temperature measurement daily. | Daily from enrollment to the 7th day. |
| Breathing rate | During the intervention period, record the patient's breathing rate measurement daily. |
Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoxia Zhang | Contact | +86-010-84013192 | 2721064904@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine | Recruiting | Beijing | 100007 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 27, 2026 | Mar 25, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Inclusion criteria:
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| Placebo | Other | 5% Yiqilishui Granules + 95% Dextrin; |
|
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 |
| At enrollment, on the 3rd day, the 7th day, and the 14th day |
| 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 | At enrollment, on the 3rd day, the 7th day, and the 14th day |
| 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. | At enrollment, on the 3rd day, the 7th day, and the 14th day |
| MEE | At the time of subject enrollment, on the 3rd day, 7th day, and 14th day, myocardial energy expenditure | At enrollment, on the 3rd day, the 7th day, and the 14th day |
| LVMI | At the time of subject enrollment, on the 3rd day, 7th day, and 14th day, left ventricular mass index (LVMI) were measured using transthoracic echocardiography to evaluate the subjects' cardiac function and structure. | At enrollment, on the 3rd day, the 7th day, and the 14th day |
| The levels of WBC | Blood is drawn from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day. The levels of white blood cells (WBC) in the subjects' venous blood is detected. | At enrollment, on the 3rd day, the 7th day, and the 14th day |
| The percentage of NE% | Blood is drawn from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day. The percentage of neutrophils (NE%) in the subjects' venous blood is detected. | At enrollment, on the 3rd day, the 7th day, and the 14th day |
| The levels of CRP | Blood is drawn from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day. The levels of C-reactive protein (CRP) in the subjects' venous blood is detected. | At enrollment, on the 3rd day, the 7th day, and the 14th day |
| The levels of PCT | Blood is drawn from the median cubital vein of the subjects at enrollment, on the 3rd day, the 7th day, and the 14th day. The levels of procalcitonin (PCT) in the subjects' venous blood is detected. | At enrollment, on the 3rd day, the 7th day, and the 14th day |
| Concentration of IL-6 | The supernatant serum is obtained by centrifugation, and the levels of interleukin-6 (IL-6) is measured by ELISA. | At enrollment, on the 3rd day, the 7th day, and the 14th day |
| Concentration of TNF-α | The supernatant serum is obtained by centrifugation, and the levels of tumor necrosis factor-α (TNF-α) is measured by ELISA. | At enrollment, on the 3rd day, the 7th day, and the 14th day |
| Concentration of ROS | The supernatant serum is obtained by centrifugation, and reactive oxygen species (ROS)is measured by ELISA. | At enrollment, on the 3rd day, the 7th day, and the 14th day |
| Concentration of ATP | The supernatant serum is obtained by centrifugation, and the levels of ATP content in the subjects' serum is measured by ELISA. | At enrollment, on the 3rd day, the 7th day, and the 14th day |
| Platelet aggregation rate | At enrollment, D3, D7, and D14, venous blood from patients is collected, platelet-rich plasma is prepared using differential centrifugation, and the platelet aggregation rate is determined by optical turbidimetry. | At enrollment, on the 3rd day, the 7th day, and the 14th day |
| SOFA score | Sequential Organ Failure Assessment (SOFA score) is performed at the time of enrollment, on the 7th day, and on the 14th day. The SOFA score includes six systems: respiratory, circulation, liver, coagulation, kidney and central nervous system. Each system is scored according to different variables, with a score of 0 to 4 points, and a total score of 0 to 24 points. The higher the score, the worse the outcome. | At enrollment, the 7th day, and the 14th day |
| Apache II score | Acute Physiology and Chronic Health Evaluation (Apache II score) is performed at the time of enrollment, on the 7th day, and on the 14th day. The Apache II score is scored from 0 to 71, and the higher the score, the worse the outcome. | At enrollment, the 7th day, and the 14th day |
| ICU length of stay; | ICU length of stay，up to 100 weeks. | From the date the participant is transferred to the ICU to the date he or she is finally transferred out of the ICU, assessed up to 100 weeks. |
| Outcome indicator | 28-day mortality rate | 28th day |
| Daily from enrollment to the 7th day. |
| Heart rate | During the intervention period, record the patient's heart rate measurement daily. | Daily from enrollment to the 7th day. |
| The levels of blood pressure | During the intervention period, record the patient's blood pressure measurement daily. | Daily from enrollment to the 7th day. |
| The levels of ALT | Before and after intervention period, record the patient's the levels of ALT. | At enrollment and on the 7th day. |
| The levels of AST | Before and after intervention period, record the patient's the levels of AST. | At enrollment and on the 7th day. |
| The levels of BUN | Before and after intervention period, record the patient's the levels of BUN. | At enrollment and on the 7th day. |
| The levels of Cr | Before and after intervention period, record the patient's the levels of Cr. | At enrollment and on the 7th day. |
| The levels of PT | Before and after intervention period, record the patient's the levels of Prothrombin Time(PT). | At enrollment and on the 7th day. |
| The levels of APTT | Before and after intervention period, record the patient's the levels of Activated Partial Thromboplastin Time(APTT). | At enrollment and on the 7th day. |
| The levels of INR | Before and after intervention period, record the patient's the levels of international normalized ratio(INR). | At enrollment and on the 7th day. |
| The levels of TT | Before and after intervention period, record the patient's the levels of Thrombin Time(TT). | At enrollment and on the 7th day. |
| The levels of D-D | Before and after intervention period, record the patient's the levels of D-dimer(D-D). | At enrollment and on the 7th day. |
| The levels of FDP | Before and after intervention period, record the patient's the levels of Fibrin degradation products(FDP). | At enrollment and on the 7th day. |
| Unexpected adverse reactions | Unexpected adverse reactions occurred during the intervention period. | From enrollment to the 7th day, unexpected adverse reactions should be recorded at any time during the intervention period. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |