An interventional study of Xuanbai Chengqi Decoction and Xuanbai Chengqi Decoction; Forest-Cultivated Ginseng in Sepsis, sponsored by Shanghai Jiao Tong University School of Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment
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.
Background： 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.
This project aims to establish an integrated Chinese and Western medicine collaborative diagnosis and treatment mechanism for sepsis and a standardized "Traditional Chinese Medicine (TCM)-based comprehensive intestinal management protocol." In early sepsis, Xuanbai Chengqi Decoction will be used to protect the intestine and lungs, reduce the systemic inflammatory response, and protect multiple organ functions. In the intermediate and late stages, when patients develop immunosuppression (monocytic HLA-DR [mHLA-DR] \<30%, decreased CD3+ and CD4+ lymphocytes, and a reduced CD4+/CD8+ ratio), forest-cultivated ginseng will be added to modulate immune function. Concurrently, clinical and basic studies will be conducted to clarify whether the TCM-based comprehensive intestinal management protocol can improve therapeutic efficacy and prognosis in sepsis and to elucidate the possible mechanisms. A clinical big data center for integrated Chinese and Western medicine in sepsis will also be established to facilitate clinical research, thereby further improving the level of sepsis care.
Methods： This is a prospective, randomized, double-blind, placebo-controlled clinical trial. Adults aged 18-80 years who meet the Sepsis-3 criteria-infection-induced organ dysfunction defined as an increase of ≥2 points from baseline in the Sequential Organ Failure Assessment (SOFA) score-will be enrolled after signing informed consent.
Interventions： Participants will be randomly allocated using block randomization (sequence generated by an independent statistician using a sampling function).
All study medications will be sealed in coded envelopes to maintain blinding. Before administration, granules will be dissolved in 100 mL of warm water and administered once daily via a nasogastric tube for 7 consecutive days. All groups will receive standard Western medical treatment for sepsis. Treatment assignment will be unblinded only for serious adverse events for which knowledge of the treatment is required, with ethics committee approval.
Outcomes： The primary outcome is improvement in the SOFA score at day 7 (a measure of organ function).
Secondary outcomes include inflammatory response markers, immune markers, coagulation parameters, multiple organ function (heart, lung, liver, kidney, intestine) parameters, gastrointestinal function score, SOFA score, and ISTH-DIC score at different time points (days 1, 3, 5, 7, 14, 21, and 28), as well as organ function support, 28-day mortality, ICU and hospital length of stay, and adverse events.
Sample Size： In patients with sepsis, the 7-day SOFA score is 7.6. Assuming a 10% reduction in SOFA in all three intervention groups, a standard deviation of 1.5, a significance level of 0.05, and 80% power, 62 participants are required per group. Accounting for a 10% dropout rate, 70 participants will be enrolled per group, for a total of 280 participants.
Statistical Analysis：
1）Primary endpoint analysis： SOFA score at 7 days after enrollment: Descriptive statistics will be provided for each visit and for changes from baseline at each visit. Between-group comparisons will be performed using the independent-samples t-test or Wilcoxon rank-sum test, and within-group comparisons will be performed using the paired t-test or paired signed-rank test.
2)Secondary endpoint analyses：
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 280 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
Chronic failure of the heart, lung, liver, or kidney before admission, defined as:
i. Chronic heart failure: long-term use of a left ventricular assist device (LVAD) or inotropic agents such as milrinone; ii. Chronic respiratory failure: long-term use of a home non-invasive oxygen therapy device; iii. Liver function classified as class C; iv. Chronic renal failure: requiring regular hemodialysis.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Xuanbai Chengqi Decoction
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.
Other: Xuanbai Chengqi Decoction; Forest-Cultivated Ginseng
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.
Other: Xuanbai Yiqi Decoction
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.
Other: Inactive Chinese Herbal Decoction Placebo
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.
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.
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.
Time frame: From baseline (before the first dose) to Day 7
All-cause mortality at 28 days
All-cause mortality at 28 days after enrollment.
Time frame: 28 days
Duration of intensive care unit (ICU) stay
Duration of ICU stay, calculated from ICU admission to ICU discharge using medical records and reported in days.
Time frame: From enrollment to ICU discharge (assessed up to Day 28)
Duration of total hospital stay
Total hospital length of stay, calculated from hospital admission to hospital discharge using medical records and reported in days.
Time frame: From enrollment to hospital discharge (assessed up to Day 28)
Change in prothrombin time (PT) from baseline to Day 28
PT will be measured in plasma using an automated coagulation analyzer and reported in seconds.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in activated partial thromboplastin time (APTT) from baseline to Day 28
APTT will be measured in plasma using an automated coagulation analyzer and reported in seconds.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in international normalized ratio (INR) from baseline to Day 28
INR will be calculated from prothrombin time using an automated coagulation analyzer and reported as a dimensionless ratio.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in fibrinogen concentration from baseline to Day 28
Fibrinogen concentration will be measured in plasma using an automated coagulation analyzer and reported in g/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in D-dimer concentration from baseline to Day 28
D-dimer concentration will be measured in plasma using an immunoassay and reported in mg/L fibrinogen-equivalent units (FEU).
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in platelet count from baseline to Day 28
Platelet count will be measured in whole blood using an automated hematology analyzer and reported as ×10⁹/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in white blood cell (WBC) count from baseline to Day 28
WBC count will be measured in whole blood using an automated hematology analyzer and reported as ×10⁹/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in neutrophil percentage from baseline to Day 28
Neutrophil percentage will be measured in whole blood using an automated hematology analyzer and reported as a percentage of total leukocytes.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in C-reactive protein (CRP) concentration from baseline to Day 28
CRP concentration will be measured in serum using an immunoassay and reported in mg/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in procalcitonin (PCT) concentration from baseline to Day 28
PCT concentration will be measured in serum using an immunoassay and reported in ng/mL.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in lactate concentration from baseline to Day 28
Lactate concentration will be measured in arterial blood using a blood gas analyzer and reported in mmol/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in arterial blood pH from baseline to Day 28
Arterial blood pH will be measured using a blood gas analyzer and reported as a dimensionless value.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in arterial partial pressure of oxygen (PaO2) from baseline to Day 28
PaO2 will be measured in arterial blood using a blood gas analyzer and reported in mmHg.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in arterial partial pressure of carbon dioxide (PaCO2) from baseline to Day 28
PaCO2 will be measured in arterial blood using a blood gas analyzer and reported in mmHg.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in alanine aminotransferase (ALT) concentration from baseline to Day 28
ALT will be measured in serum using an automated biochemical analyzer and reported in U/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in aspartate aminotransferase (AST) concentration from baseline to Day 28
AST will be measured in serum using an automated biochemical analyzer and reported in U/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in total bilirubin concentration from baseline to Day 28
Total bilirubin will be measured in serum using an automated biochemical analyzer and reported in μmol/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in serum albumin concentration from baseline to Day 28
Albumin will be measured in serum using an automated biochemical analyzer and reported in g/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in serum creatinine concentration from baseline to Day 28
Creatinine will be measured in serum using an automated biochemical analyzer and reported in μmol/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in blood urea nitrogen (BUN) concentration from baseline to Day 28
BUN will be measured in serum using an automated biochemical analyzer and reported in mmol/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in serum sodium concentration from baseline to Day 28
Sodium will be measured in serum using an automated biochemical analyzer and reported in mmol/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in serum potassium concentration from baseline to Day 28
Potassium will be measured in serum using an automated biochemical analyzer and reported in mmol/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in creatine kinase (CK) concentration from baseline to Day 28
CK will be measured in serum using an automated biochemical analyzer and reported in U/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in creatine kinase-MB (CK-MB) concentration from baseline to Day 28
CK-MB will be measured in serum using an automated biochemical analyzer and reported in U/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in cardiac troponin I (cTnI) concentration from baseline to Day 28
cTnI will be measured in serum using an immunoassay and reported in ng/mL.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in B-type natriuretic peptide (BNP) concentration from baseline to Day 28
BNP will be measured in plasma using an immunoassay and reported in pg/mL.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in absolute CD3+ T-cell count from baseline to Day 28
Absolute CD3+ T-cell count will be measured in peripheral blood using flow cytometry and reported as cells/μL.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in absolute CD4+ T-cell count from baseline to Day 28
Absolute CD4+ T-cell count will be measured in peripheral blood using flow cytometry and reported as cells/μL.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in absolute CD8+ T-cell count from baseline to Day 28
Absolute CD8+ T-cell count will be measured in peripheral blood using flow cytometry and reported as cells/μL.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in serum immunoglobulin A (IgA) concentration from baseline to Day 28
IgA will be measured in serum using an immunoassay and reported in g/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in serum immunoglobulin G (IgG) concentration from baseline to Day 28
IgG will be measured in serum using an immunoassay and reported in g/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in serum immunoglobulin M (IgM) concentration from baseline to Day 28
IgM will be measured in serum using an immunoassay and reported in g/L.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in plasma interleukin-2 receptor (IL-2R) concentration from baseline to Day 28
IL-2R will be measured in plasma using an immunoassay and reported in pg/mL.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in plasma interleukin-1 beta (IL-1β) concentration from baseline to Day 28
IL-1β will be measured in plasma using an immunoassay and reported in pg/mL.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in plasma interleukin-6 (IL-6) concentration from baseline to Day 28
IL-6 will be measured in plasma using an immunoassay and reported in pg/mL.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in plasma interleukin-10 (IL-10) concentration from baseline to Day 28
IL-10 will be measured in plasma using an immunoassay and reported in pg/mL.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in plasma tumor necrosis factor-alpha (TNF-α) concentration from baseline to Day 28
TNF-α will be measured in plasma using an immunoassay and reported in pg/mL.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in plasma interleukin-8 (IL-8) concentration from baseline to Day 28
IL-8 will be measured in plasma using an immunoassay and reported in pg/mL.
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in gut microbiota composition from baseline to Day 7, assessed by 16S rRNA gene sequencing
Gut microbiota composition will be assessed in fecal samples using 16S rRNA gene sequencing and reported as relative abundance of bacterial taxa at the phylum and genus levels, together with alpha diversity indices (Shannon and Chao1 indices).
Time frame: From baseline (Day 1) to Day 7
Change in serum kynurenic acid concentration from baseline to Day 7, measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS)
Serum kynurenic acid concentration will be quantified by LC-MS/MS and reported in μmol/L.
Time frame: From baseline (Day 1) to Day 7
Change in fecal kynurenic acid concentration from baseline to Day 7, measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS)
Fecal kynurenic acid concentration will be quantified by LC-MS/MS and reported in nmol/g of feces.
Time frame: From baseline (Day 1) to Day 7
Change in serum metabolic profile from baseline to Day 7, assessed by untargeted metabolomics using LC-MS/MS
Serum metabolites will be profiled by untargeted LC-MS/MS metabolomics and reported as relative peak abundance of identified metabolites and pathway-level summary scores.
Time frame: From baseline (Day 1) to Day 7
Change in intestinal epithelial DC-SIGN expression from baseline to Day 7, assessed by immunohistochemistry
Intestinal epithelial DC-SIGN expression will be assessed by immunohistochemistry on intestinal mucosal biopsy specimens and reported as the percentage of DC-SIGN-positive epithelial cells and mean optical density.
Time frame: From baseline (Day 1) to Day 7
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2028, 19 months later.
Of 301 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 19 months is below that.
Counting every sponsor, half of 324 studies reached it within 22 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Jiao Tong University School of Medicine →