Sepsis
Conditions
Interventions
The control group treated with western medicine:Standardized Western Medical Treatment (based on the recommendations of the "Guidelines for the Diagnosis and Treatment of Sepsis" (2023 Edition) to imp
The control group treated with Shengjiang Powder:Combined treatment with Shengjiang San on the basis of standardized Western medicine therapy
Treatment group receiving Yong'an Shengjiang Decoction:Combined treatment with Yong'an Shengjiang decoctionon the basis of standardized Western medicine therapy
Sponsors
Nanjing City Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1: Patients who meet the diagnostic criteria for sepsis 3.0( Diagnostic criteria for sepsis3.0 should simultaneously meet the following two conditions:1) Confirmed or suspected infection.2) The SOFA score has increased by =2 points compared with the baseline.) 2: Patients who meet the traditional Chinese medicine diagnostic criteria for sepsis belonging to the Syndrome of Excessive Heat in Qi Phase( TCM diagnostic criteria refer to the 2014 Expert Consensus on TCM Diagnosis and Treatment of High Fever (Sepsis) for Syndrome of Excessive Heat in Qi Phase: Main symptoms: high fever without chills; red tongue with yellow-dry or grayish-black prickly coating; deep and rapid forceful pulse; Accompanying symptoms: thirst; sweating; abdominal distension and fullness;abdominal pain aggravated by pressure;constipation or diarrhea with foul-smelling, yellowish, watery stool; flushed face; restlessness; delirium; convulsions, etc.Diagnosis is confirmed if 2 main symptoms and at least 2 secondary symptoms are present) 3: Patients aged between 18 and 85 years old. 4: Patients or their legal guardian has provided signed informed consent.
Exclusion criteria
Exclusion criteria: 1: Pregnant or lactating women; 2: Patients with severe malignancies, severe autoimmune diseases, or complicated with severe cardiac diseases, hepatic diseases, or renal diseases; 3: Patients on long-term immunosuppressive therapy; 4: Patients allergic to the traditional Chinese medicines used or any of its known components; 5: Patients unable to take traditional Chinese medicines due to therapeutic requirements such as fasting or invasive mechanical ventilation; 6: Patients with severe psychological disorders or mental illnesses that may affect the assessment of TCM syndrome scores 7: Patients who do not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sequential Organ Failure Assessment(SOFA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Coagulation indicators (including: platelet count, plasma prothrombin time, activated partial thromboplastin time, international normalized ratio, plasma thrombin time, plasma fibrinogen, D-dimer);Inflammatory markers (including: C-reactive protein, white blood cell count, neutrophil percentage, neutrophil count, procalcitonin);Traditional Chinese Medicine Symptom Score;Acute Physical and Chronic Health Status Score II (APACHE II);China Disseminated Intravascular Coagulation Diagnosis Score System (CDSS);Arterial Blood Gas Analysis; | — |
Countries
China
Contacts
Public ContactYanliang Zhang
Nanjing Hospital of Traditional Chinese Medicine
Outcome results
None listed