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Life sciences · Interventional Study
ClinicalTrials.gov · October 28, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07902024). This is a study registration, not published results. Lead sponsor: Shanghai Jiao Tong University School of Medicine. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 280 participants (ESTIMATED). Conditions: Sepsis. Interventions: OTHER: Xuanbai Chengqi Decoction; OTHER: Xuanbai Chengqi Decoction; Forest-Cultivated Ginseng; OTHER: Xuanbai Yiqi Decoction; OTHER: Inactive Chinese Herbal Decoction Placebo. Primary outcome measures: Change in SOFA score from baseline to Day 7 , From baseline (before the first dose) to Day 7. Brief summary: Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Multiple organ dysfunction syndrome (MODS) is the leading cause of sepsis-related death. Early in sepsis, intestinal barrier injury and gut microbiota dysbiosis occur, and gut-derived toxins and inflammatory cytokines act on the lungs and the whole body via the gut-liver-lung axis, representing an important pathophysiological mechanism. In the intermediate and late stages of the disease, patients generally develop immunosuppression. Our team intends to establish a Traditional Chinese Medicine (TCM)-based comprehensive intestinal management protocol. Xuanbai Chengqi Decoction will be used in early sepsis. In the intermediate-to-late stage, when immunosuppression occurs (monocytic HLA-DR \[mHLA-DR\] expression \<30%, decreased CD3+ and CD4+ lymphocyte counts, and a reduced CD4+/CD8+ ratio), Xuanbai Yiqi Decoction supplemented with forest-cultivated ginseng will be used, combined with acupuncture, to protect multiple organs including the intestine and lungs and to modulate immunity.This is a prospective, randomized, double-blind, placebo-controlled clinical trial enrolling 280 patients with sepsis hospitalized in the Department of Emergency Medicine and the Department of Critical Care Medicine at Ruijin Hospital. Patients with sepsis who meet all inclusion and exclusion criteria at admission will be randomly assigned to the control group, Xuanbai Chengqi Decoction group, Xuanbai Chengqi Decoction plus forest-cultivated ginseng group, or Xuanbai Yiqi Decoction group. The granules will be dissolved in 100 mL of warm water and administered once daily via a nasogastric tube for 7 consecutive days, in addition to standard sepsis treatment.The primary outcome is improvement in the Sequential Organ Failure Assessment (SOFA) score at day 7 (a measure of organ function). Secondary outcomes include disseminated intravascular coagulation (DIC) score, coagulation tests, endothelial injury and platelet markers, inflammatory markers, 28-day mortality, intensive care unit (ICU) and hospital length of stay, and adverse events.The study is funded by Ruijin Hospital and is conducted as an investigator-initiated trial.