Evidence-based Evaluation and Mechanism of Shenhuang Granules in the Treatment of Sepsis

• Baseline data: patient's name, gender, age, enrollment diagnosis, sepsis diagnosis time, combined underlying disease, allergy history, personal history, body temperature, respiration, heart rate, blood pressure, blood oxygen saturation and other vital signs.
• Primary outcome measure: 28-day mortality
• Secondary outcome indicators:

A. Total length of stay and ICU stay B. Total hospitalization costs and ICU hospitalization costs C. Overall mortality and ICU mortality D.28 days cumulative no mechanical ventilation time E. Information of TCM syndrome such as tongue and pulse on day 0 and day 5-7 F. TCM symptom scores on days 0 and 5-7 G. SOFA score and APACHE II score on days 0 and 5-7.

• Other observation indicators (day 0 and 7) :

A. Inflammatory markers: WBC, percentage of neutrophils, CRP, PCT, tumor necrosis factor (TNF-α), interleukin-6 (IL-6), interleukin-10 (IL-10); B. Main organ function indicators: BNP, TnI, creatinine, urea nitrogen, total bilirubin, direct bilirubin, indirect bilirubin, AST, ALT, arterial lactic acid; C. Coagulation indicators: PT, APTT; D. Immune function: absolute number of lymphocytes, number of CD4+T cells, number of CD8+T cells, number of B cells, number of NK cells.

• Safety indicators: adverse reaction symptoms or adverse events (such as allergies).

If you need to collect stool and blood samples, you also need to observe the following indicators, if not, please ignore.

• Metabolomic study: Serum samples from day 0 and day 5-7 were collected for the study of the main functional components of Shenhuang granules and metabolomic analysis;
• Intestinal microecology study: Stool samples from day 0 and day 5-7 were collected for intestinal microecology study.

Inclusion criteria

• Age ≥18 years old
• Meet the diagnostic criteria of sepsis 3.0 guidelines
• Sign informed consent.

Exclusion criteria

• Liver or kidney single SOFA score ≥3 points of liver and kidney dysfunction
• Death is expected within 48 hours, or SOFA≥15 points, or APACHE II ≥30 points, or the patient refuses active treatment
• Patients with allergic reactions to traditional Chinese medicine
• Patients treated with chemotherapy or radiotherapy or high-dose immunosuppressants within the last 1 month
• Participants in other clinical trials at the same time or within 30 days
• Pregnant and lactating women
• Patients with severe gastrointestinal bleeding, intestinal obstruction, or severe intraperitoneal pressure elevation (IAP≥20mmHg).