SepsisTCM-CIM-SEPSISNCT07902024
Xuanbai Yiqi Decoction for Sepsis: A Randomized Controlled Trial
A study testing Xuanbai Chengqi Decoction, Xuanbai Chengqi Decoction; Forest-Cultivated Ginseng and Xuanbai Yiqi Decoction in people with Sepsis, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Xuanbai Chengqi Decoction, Xuanbai Chengqi Decoction; Forest-Cultivated Ginseng and Xuanbai Yiqi Decoction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤80 years.
- Patients meeting the updated diagnostic criteria for sepsis (Sepsis-3), defined as infection-induced organ dysfunction with an increase of ≥2 points from baseline in the Sequential Organ Failure Assessment (SOFA) score (see table).
- Provision of signed informed consent. Patients must meet all of the above criteria to be eligible for inclusion.
Who cannot join
- Pregnant or breastfeeding women.
- Patients with advanced-stage cancer.
- Concurrent autoimmune disease.
- Chronic failure of the heart, lung, liver, or kidney before admission, defined as:
- 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 Child-Pugh class C; iv. Chronic renal failure: requiring regular hemodialysis.
- Concurrent psychiatric disorders.
- Known allergic diathesis or hypersensitivity to any study drug. Patients meeting any of the above criteria will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Emergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Li Ma, MD, PhD, +86-15921615410, Malipostgraduate2@163.com
About this study
Official title: Efficacy and Safety of Xuanbai Yiqi Decoction in Patients With Sepsis: a Randomized, Double-blind, Controlled, Four-arm, Prospective Trial
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.
Read the detailed description
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).
- Xuanbai Chengqi Decoction group: Xuanbai Chengqi Decoction will be administered.
- Xuanbai Chengqi Decoction + forest-cultivated ginseng group: Xuanbai Chengqi Decoction will be administered, and immune function will be monitored. Once immunosuppression occurs, forest-cultivated ginseng 9 g will be added to Xuanbai Chengqi Decoction.
- Xuanbai Yiqi Decoction group: Xuanbai Yiqi Decoction will be administered.
- Control group: An inactive Chinese herbal decoction placebo will be administered, designed to simulate the odor and to ensure physicochemical properties comparable to the investigational drugs, with the same administration route and treatment duration.
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：
- Between-group comparisons for immune markers, infection markers, coagulation parameters, gut microbiota, metabolomics, and intestinal barrier function (serum/feces kynurenic acid) will be performed using the independent-samples t-test or Wilcoxon rank-sum test.
- Duration of mechanical ventilation, continuous renal replacement therapy (CRRT), and vasoactive drug use: between-group comparisons will be performed using the independent-samples t-test or Wilcoxon rank-sum test.
- 28-day mortality: mortality will be calculated using the Kaplan-Meier method, and between-group comparisons will be performed using the log-rank test.
- Conditions
- Sepsis
- Being tested
- Xuanbai Chengqi Decoction, Xuanbai Chengqi Decoction; Forest-Cultivated Ginseng, Xuanbai Yiqi Decoction, Inactive Chinese Herbal Decoction Placebo
- Keywords
- Chinese herbal medicine, gut-lung axis, Xuanbai Yiqi Decoction, sepsis, immune regulation, SOFA score
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xuanbai Chengqi DecoctionOther
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 GinsengOther
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 DecoctionOther
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 PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Xuanbai Chengqi Decoction Group | Experimental | 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. Receives: Other: Xuanbai Chengqi Decoction |
| Xuanbai Chengqi Decoction + Forest-Cultivated Ginseng Group | Experimental | 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. Receives: Other: Xuanbai Chengqi Decoction; Forest-Cultivated Ginseng |
| Xuanbai Yiqi Decoction Group | Experimental | 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. Receives: Other: Xuanbai Yiqi Decoction |
| Control Group | Placebo comparator | 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. Receives: Other: Inactive Chinese Herbal Decoction Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (before the first dose) to Day 7
Secondary outcomes (46)
All-cause mortality at 28 days
All-cause mortality at 28 days after enrollment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline (Day 1) to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in parallel to 4 arms: a control group, a Xuanbai Chengqi Decoction group, a Xuanbai Chengqi Decoction plus forest-cultivated ginseng group, and a Xuanbai Yiqi Decoction group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Ma, Ruijin Hospital
- Investigators
- Li Ma, Study director, Emergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902024
- Sponsor's protocol ID
- MR-31-24-056083
- Other IDs
- 2024-536
- Acronym
- TCM-CIM-SEPSIS
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Xuanbai Yiqi Decoction in Patients With Sepsis: a Randomized, Double-blind, Controlled, Four-arm, Prospective Trial
- ClinicalTrials.gov ID
- NCT07902024
- Acronym / sponsor ID
- TCM-CIM-SEPSIS / MR-31-24-056083
- Conditions
- Sepsis
- Keywords
- Chinese herbal medicine, gut-lung axis, Xuanbai Yiqi Decoction, sepsis, immune regulation, SOFA score
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
- Xuanbai Chengqi Decoction group: Xuanbai Chengqi Decoction will be administered.
- Xuanbai Chengqi Decoction + forest-cultivated ginseng group: Xuanbai Chengqi Decoction will be administered, and immune function will be monitored. Once immunosuppression occurs, forest-cultivated ginseng 9 g will be added to Xuanbai Chengqi Decoction.
- Xuanbai Yiqi Decoction group: Xuanbai Yiqi Decoction will be administered.
- Control group: An inactive Chinese herbal decoction placebo will be administered, designed to simulate the odor and to ensure physicochemical properties comparable to the investigational drugs, with the same administration route and treatment duration.
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：
- Between-group comparisons for immune markers, infection markers, coagulation parameters, gut microbiota, metabolomics, and intestinal barrier function (serum/feces kynurenic acid) will be performed using the independent-samples t-test or Wilcoxon rank-sum test.
- Duration of mechanical ventilation, continuous renal replacement therapy (CRRT), and vasoactive drug use: between-group comparisons will be performed using the independent-samples t-test or Wilcoxon rank-sum test.
- 28-day mortality: mortality will be calculated using the Kaplan-Meier method, and between-group comparisons will be performed using the log-rank test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants are randomized in parallel to 4 arms: a control group, a Xuanbai Chengqi Decoction group, a Xuanbai Chengqi Decoction plus forest-cultivated ginseng group, and a Xuanbai Yiqi Decoction group.
| Arm | Type | Receives |
|---|---|---|
| Xuanbai Chengqi Decoction Group | Experimental | Other: Xuanbai Chengqi DecoctionIn 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. |
| Xuanbai Chengqi Decoction + Forest-Cultivated Ginseng Group | Experimental | Other: Xuanbai Chengqi Decoction; Forest-Cultivated GinsengIn 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 Yiqi Decoction Group | Experimental | Other: Xuanbai Yiqi DecoctionIn 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. |
| Control Group | Placebo comparator | Other: Inactive Chinese Herbal Decoction PlaceboIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years and ≤80 years.
- Patients meeting the updated diagnostic criteria for sepsis (Sepsis-3), defined as infection-induced organ dysfunction with an increase of ≥2 points from baseline in the Sequential Organ Failure Assessment (SOFA) score (see table).
- Provision of signed informed consent. Patients must meet all of the above criteria to be eligible for inclusion.
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding women.
- Patients with advanced-stage cancer.
- Concurrent autoimmune disease.
- Chronic failure of the heart, lung, liver, or kidney before admission, defined as:
- Concurrent psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xuanbai Chengqi DecoctionXuanbai 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. | Other | Xuanbai Chengqi Decoction Group |
| Xuanbai Chengqi Decoction; Forest-Cultivated GinsengXuanbai 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. | Other | Xuanbai Chengqi Decoction + Forest-Cultivated Ginseng Group |
| Xuanbai Yiqi DecoctionXuanbai 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. | Other | Xuanbai Yiqi Decoction Group |
| Inactive Chinese Herbal Decoction PlaceboAn 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. | Other | Control Group |
Primary outcome
Change in SOFA score from baseline to Day 7
Time frame: From baseline (before the first dose) 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.
46 secondary outcomes
All-cause mortality at 28 days
Time frame: 28 days
Duration of intensive care unit (ICU) stay
Time frame: From enrollment to ICU discharge (assessed up to Day 28)
Duration of total hospital stay
Time frame: From enrollment to hospital discharge (assessed up to Day 28)
Change in prothrombin time (PT) from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in activated partial thromboplastin time (APTT) from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in international normalized ratio (INR) from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in fibrinogen concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in D-dimer concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in platelet count from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in white blood cell (WBC) count from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in neutrophil percentage from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in C-reactive protein (CRP) concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in procalcitonin (PCT) concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in lactate concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in arterial blood pH from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in arterial partial pressure of oxygen (PaO2) from baseline to Day 28
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
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in alanine aminotransferase (ALT) concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in aspartate aminotransferase (AST) concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in total bilirubin concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in serum albumin concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in serum creatinine concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in blood urea nitrogen (BUN) concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in serum sodium concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in serum potassium concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in creatine kinase (CK) concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in creatine kinase-MB (CK-MB) concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in cardiac troponin I (cTnI) concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in B-type natriuretic peptide (BNP) concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in absolute CD3+ T-cell count from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in absolute CD4+ T-cell count from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in absolute CD8+ T-cell count from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in serum immunoglobulin A (IgA) concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in serum immunoglobulin G (IgG) concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in serum immunoglobulin M (IgM) concentration from baseline to Day 28
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
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
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in plasma interleukin-6 (IL-6) concentration from baseline to Day 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Change in plasma interleukin-10 (IL-10) concentration from baseline to Day 28
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
Time frame: Days 1, 3, 5, 7, 14, 21, and 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Ma study director
Emergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xuanbai Chengqi Decoction, Xuanbai Chengqi Decoction; Forest-Cultivated Ginseng and Xuanbai Yiqi Decoction in people with Sepsis, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Ma (+86-15921615410, Malipostgraduate2@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SOFA score from baseline to Day 7 (time frame: From baseline (before the first dose) to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.