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Xuanbai Yiqi Decoction for Sepsis: A Randomized Controlled Trial
Sponsor: Shanghai Jiao Tong University School of Medicine
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.
Official title: Efficacy and Safety of Xuanbai Yiqi Decoction in Patients With Sepsis: a Randomized, Double-blind, Controlled, Four-arm, Prospective Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2026-11-01
Completion Date
2028-07-31
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Xuanbai Chengqi Decoction
Xuanbai Chengqi Decoction (raw gypsum 30 g, raw rhubarb 12 g, bitter apricot seed 18 g, Trichosanthes peel 18 g) is decocted in water to 100 mL and administered twice daily on days 1-7 after enrollment, in addition to standard Western medical treatment for sepsis.
Xuanbai Chengqi Decoction; Forest-Cultivated Ginseng
Xuanbai Chengqi Decoction is administered on days 1-7 after enrollment. If immunosuppression develops, forest-cultivated ginseng 9 g is added. The modified decoction (raw gypsum 30 g, raw rhubarb 12 g, bitter apricot seed 18 g, Trichosanthes peel 18 g, forest-cultivated ginseng 9 g) is decocted in water to 200 mL and administered once daily, in addition to standard Western medical treatment for sepsis.
Xuanbai Yiqi Decoction
Xuanbai Yiqi Decoction (raw gypsum 30 g, raw rhubarb 12 g, bitter apricot seed 18 g, Trichosanthes peel 18 g, forest-cultivated ginseng 3 g) is decocted in water to 200 mL and administered once daily on days 1-7 after enrollment, in addition to standard Western medical treatment for sepsis.
Inactive Chinese Herbal Decoction Placebo
An inactive Chinese herbal decoction placebo designed to simulate odor and to ensure physicochemical properties comparable to the investigational drugs, administered with the same route and treatment duration as the active interventions, in addition to standard Western medical treatment for sepsis.
Locations (1)
Emergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China