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TCM-CIM-SEPSIS
Efficacy and Safety of Xuanbai Yiqi Decoction in Patients With Sepsis: a Randomized, Double-blind, Controlled, Four-arm, Prospective Trial
Sponsor study identifier
Secondary identifiers
OTHER · Ethics Committee of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
interventional
280
1 country
1
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 13, 2026
Actual (reported)October 28, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in SOFA score from baseline to Day 7
The Sequential Organ Failure Assessment (SOFA) score is a measure of organ dysfunction (range 0-24, with higher scores indicating more severe dysfunction). The primary endpoint is the improvement between the four groups, defined as baseline SOFA score minus Day 7 SOFA score. SOFA score is assessed at baseline (before the first dose) and on Day 7.
From baseline (before the first dose) to Day 7
All-cause mortality at 28 days
28 days
Duration of intensive care unit (ICU) stay
From enrollment to ICU discharge (assessed up to Day 28)
Duration of total hospital stay
From enrollment to hospital discharge (assessed up to Day 28)
Change in prothrombin time (PT) from baseline to Day 28
Days 1, 3, 5, 7, 14, 21, and 28
Change in activated partial thromboplastin time (APTT) from baseline to Day 28
Days 1, 3, 5, 7, 14, 21, and 28
In addition to standard Western medical treatment for sepsis, participants receive Xuanbai Chengqi Decoction on days 1-7 after enrollment. The decoction consists of raw gypsum 30 g, raw rhubarb 12 g, bitter apricot seed 18 g, and Trichosanthes peel 18 g; it is decocted in water to 100 mL and administered twice daily.
In addition to standard Western medical treatment for sepsis, participants receive Xuanbai Chengqi Decoction on days 1-7 after enrollment, with concurrent monitoring of immune function. If immunosuppression occurs (mHLA-DR \<30%, decreased CD3+ and CD4+ lymphocytes, and reduced CD4+/CD8+ ratio), forest-cultivated ginseng 9 g is added to Xuanbai Chengqi Decoction. The modified decoction consists of raw gypsum 30 g, raw rhubarb 12 g, bitter apricot seed 18 g, Trichosanthes peel 18 g, and forest-cultivated ginseng 9 g; it is decocted in water to 200 mL and administered once daily.
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 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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Control intervention
Inactive Chinese Herbal Decoction Placebo
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry recordEmergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Li Ma
Emergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
First Submitted
October 13, 2026
First Posted
October 28, 2026
In addition to standard Western medical treatment for sepsis, participants receive Xuanbai Yiqi Decoction on days 1-7 after enrollment. The decoction consists of raw gypsum 30 g, raw rhubarb 12 g, bitter apricot seed 18 g, Trichosanthes peel 18 g, and forest-cultivated ginseng 3 g; it is decocted in water to 200 mL and administered once daily.
In addition to standard Western medical treatment for sepsis, participants receive an inactive Chinese herbal decoction placebo on days 1-7 after enrollment. The placebo is designed to simulate odor and to ensure physicochemical properties comparable to the investigational drugs, with the same administration route and treatment duration.
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.
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.
Contact the study team to confirm eligibility.
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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