An interventional study of High-dose safflower granules and Medium-dose safflower granules in Sepsis and Disseminated Intravascular Coagulation (DIC), 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 2026-10-27.
Sponsored by Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment
Sepsis is a life-threatening condition in which infection triggers widespread inflammation and blood clotting abnormalities. Many patients with sepsis develop coagulopathy (impaired blood clotting), which contributes to organ damage and death. Safflower (Carthamus tinctorius L.) is a traditional Chinese medicine herb with documented anticoagulant, anti-platelet, and blood vessel-protective properties. This randomized, double-blind, placebo-controlled trial will enroll 210 adult patients with sepsis-associated coagulopathy at Ruijin Hospital. Participants will be randomly assigned to one of three groups: high-dose safflower granules (equivalent to 9 g of raw herb daily), medium-dose safflower granules (equivalent to 6 g of raw herb daily), matching placebo (equivalent to 0.6 g of raw herb daily for blinding). The granules are dissolved in 50 mL of warm water and given through a nasogastric tube once daily for 7 days, in addition to standard sepsis treatment. The primary outcome is the improvement in the SOFA score (a measure of organ function) at 14 days. Secondary outcomes include DIC scores, coagulation tests, endothelial injury and platelet markers, inflammatory markers, 28-day mortality, length of ICU and hospital stay, and adverse events. The study is funded by Ruijin Hospital as an investigator-initiated trial.
Background: Sepsis remains a leading cause of mortality in intensive care units. Disseminated intravascular microthrombosis secondary to vascular endothelial injury plays a pivotal role in the progression to multiple organ dysfunction syndrome. Safflower (Carthamus tinctorius L.), a traditional Chinese medicine, exhibits anticoagulant, anti-platelet, endothelium-protective, and anti-inflammatory pharmacological activities, largely attributed to its principal active constituent hydroxysafflor yellow A (HSYA).
Design: This is a single-center, prospective, randomized, double-blind, three-arm trial. The comparator is a one-tenth-dose safflower preparation serving blinding only. Adults (18-80 years) meeting Sepsis 3.0 criteria with coagulopathy at admission (FDP > 9.9 mg/L and D-dimer > 3.3 mg/L) will be enrolled after written informed consent.
Interventions: Participants are randomized 1:1:1 by block randomization (generated with the sample function in R by an independent statistician) to: (1) high-dose group: safflower granules equivalent to 9 g of raw herb once daily; (2) medium-dose group: safflower granules equivalent to 6 g of raw herb once daily; (3) control group: matching placebo granules containing one-tenth of the safflower dose (equivalent to 0.6 g of raw herb), prepared solely for blinding and not intended as a therapeutic dose. All study medications are provided in sealed, coded envelopes to preserve blinding; before administration, granules are dissolved in 50 mL of warm water and instilled via nasogastric tube for 7 consecutive days or until clinical stabilization. Allocation concealment is maintained by sequentially numbered opaque envelopes opened only by an unblinded drug administrator. All groups receive guideline-directed standard sepsis care (Surviving Sepsis Campaign). Treatment assignment is unblinded only for serious adverse events requiring knowledge of treatment, with ethics committee approval.
Outcomes: The primary outcome is the change in SOFA score from baseline to Day 14. Secondary outcomes include ISTH-DIC scores, coagulation parameters, endothelial injury markers, platelet function markers, and inflammatory markers (Days 1, 2, 3, 5, 7, 14), 28-day all-cause mortality, duration of organ support, ICU and hospital length of stay, and adverse events through Day 28.
Sample size: A feasibility-based sample size of 70 patients per group (210 total) was calculated assuming a 10% reduction in 7-day SOFA score (SD 1.5, alpha 0.05, power 80%), allowing for 10% dropout.
Analysis: The intention-to-treat population will be analyzed. The primary outcome will be compared among the three groups using ANOVA or the Kruskal-Wallis test with post-hoc pairwise comparisons and multiplicity adjustment. Kaplan-Meier curves with the log-rank test will be used for survival outcomes.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 210 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.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — 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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — 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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Safflower (Carthamus tinctorius L.) granules equivalent to 9 g of raw herb, dissolved in 50 mL of warm water and given via nasogastric tube once daily for 7 consecutive days or until clinical stabilization, plus standard-of-care sepsis treatment.
Other: High-dose safflower granules
Safflower (Carthamus tinctorius L.) granules equivalent to 6 g of raw herb, dissolved in 50 mL of warm water and given via nasogastric tube once daily for 7 consecutive days or until clinical stabilization, plus standard-of-care sepsis treatment.
Other: Medium-dose safflower granules
Safflower (Carthamus tinctorius L.) granules at one-tenth of the medium dose (equivalent to 0.6 g of raw herb), dissolved in 50 mL of warm water and given via nasogastric tube once daily, same duration as the safflower groups, plus standard-of-care sepsis treatment. The one-tenth dose serves blinding by matching the appearance and odor of the study granules.
Other: Placebo granules (one-tenth of medium-dose safflower)
Safflower (Carthamus tinctorius L.) granules equivalent to 9 g of raw herb, prepared as a blinded study medication in a sealed coded envelope. Immediately before administration the granules are dissolved in 50 mL of warm water and instilled via nasogastric tube once daily for 7 consecutive days or until clinical stabilization. All participants in this arm also receive standard-of-care sepsis treatment per the Surviving Sepsis Campaign guidelines, including early antimicrobial therapy, goal-directed fluid resuscitation, and organ support as needed.
Also known as: Carthamus tinctorius L. granules
Safflower (Carthamus tinctorius L.) granules equivalent to 6 g of raw herb, prepared as a blinded study medication in a sealed coded envelope. Immediately before administration the granules are dissolved in 50 mL of warm water and instilled via nasogastric tube once daily for 7 consecutive days or until clinical stabilization. All participants in this arm also receive standard-of-care sepsis treatment per the Surviving Sepsis Campaign guidelines, including early antimicrobial therapy, goal-directed fluid resuscitation, and organ support as needed.
Also known as: Carthamus tinctorius L. granules
Safflower granules at one-tenth of the medium dose (equivalent to 0.6 g of raw herb), prepared to match the study granules in appearance and odor for blinding, in a sealed coded envelope. Immediately before administration the granules are dissolved in 50 mL of warm water and instilled via nasogastric tube once daily, for the same duration as the safflower arms, plus standard-of-care sepsis treatment per the Surviving Sepsis Campaign guidelines.
Change in SOFA score from baseline to Day 14
The Sequential Organ Failure Assessment (SOFA) score is a measure of organ dysfunction (range 0-24, higher scores indicate more severe dysfunction). The primary endpoint is the improvement value defined as the baseline SOFA score minus the Day 14 SOFA score, compared among the three groups. SOFA scores are assessed at baseline (before the first dose) and on Day 14. Component-level scores are reported separately as a pre-specified supportive outcome.
Time frame: From baseline (before the first dose) through Day 14
Change in ISTH-DIC score from baseline to Day 14
The International Society on Thrombosis and Haemostasis (ISTH) overt disseminated intravascular coagulation score, calculated at each assessment time point from platelet count, prothrombin time, fibrinogen, and D-dimer (or fibrin degradation products); a total score of 5 or more indicates overt DIC. Analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14
All-cause mortality at 28 days
All-cause mortality is defined as death from any cause within 28 days after randomization, counted for all randomized participants regardless of causality assessment. Vital status at Day 28 is collected for all participants.
Time frame: 28 days after randomization
ICU length of stay and total hospital length of stay
Duration of intensive care unit stay and total hospital stay, measured in days from randomization to ICU discharge and to hospital discharge or death, respectively, for all randomized participants.
Time frame: From randomization to hospital discharge or through study completion, an average of approximately 22 days
Change in SOFA Component Scores for Hepatic, Renal, Respiratory, and Cardiovascular Function from Baseline to Day 14
The total SOFA score (0-24) is the primary endpoint of this study; this outcome reports the pre-specified component-level analysis supporting it. The SOFA score grades six organ systems, each 0-4 points. This outcome reports the hepatic (serum total bilirubin), renal (serum creatinine or receipt of renal replacement therapy), respiratory (PaO2/FiO2 ratio), and cardiovascular (mean arterial pressure and vasopressor use) components, each scored 0-4 per the SOFA definitions in the Sepsis-3 criteria. Change is calculated as baseline minus the Day N score, consistent with the primary endpoint direction, so positive values indicate improvement; components are reported individually in points.
Time frame: From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14
Change in Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) from Baseline to Day 14
Prothrombin time (PT, seconds) and activated partial thromboplastin time (APTT, seconds) measured from venous blood samples collected at each protocol-specified time point.
Time frame: From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14
Change in International Normalized Ratio (INR) from Baseline to Day 14
The international normalized ratio (INR), calculated from the prothrombin time and the international sensitivity index (ISI) of the thromboplastin reagent used, reported as a dimensionless ratio; analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14
Change in Fibrinogen (FG) from Baseline to Day 14
Plasma fibrinogen concentration measured in venous blood samples collected at each protocol-specified time point, reported in g/L; analyzed as change from baseline. Fibrinogen is both an acute-phase reactant and the substrate of fibrin formation.
Time frame: From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14
Change in D-dimer from Baseline to Day 14
Plasma D-dimer, a marker of endogenous fibrin formation and degradation, measured in venous blood samples collected at each protocol-specified time point, reported in mg/L; analyzed as change from baseline. Elevated D-dimer at screening is an eligibility criterion of this study.
Time frame: From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14
Change in Platelet Count from Baseline to Day 14
Platelet count measured in venous blood samples collected at each protocol-specified time point, reported as 10\^9/L; analyzed as change from baseline. Platelet count is also a component of the ISTH-DIC score.
Time frame: From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14
Change in Antithrombin III (AT III), Protein C Activity, and Coagulation Factor Activities (FV, FVII, FVIII) from Baseline to Day 14
Antithrombin III activity, protein C activity, and coagulation factor V, VII, and VIII activities measured in citrated plasma at each protocol-specified time point, all reported as percent activity; each analyte analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14
Change in PAI-1, T-PAIC, and t-PA from Baseline to Day 14
Plasma plasminogen activator inhibitor-1 (PAI-1), tissue plasminogen activator-inhibitor complex (T-PAIC), and tissue-type plasminogen activator (t-PA) measured in venous blood samples at baseline and on Day 14, all reported in ng/mL; each analyte analyzed as change from baseline. Together these characterize fibrinolytic activity and its inhibition.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in Plasmin-alpha2 Plasmin Inhibitor Complex (PIC) from Baseline to Day 14
Plasma plasmin-alpha2 plasmin inhibitor complex (PIC), a marker of endogenous fibrinolysis, measured in venous blood samples at baseline and on Day 14, reported in ug/L; analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in Thromboelastography (TEG) Reaction Time (R) and Kinetics Time (K) from Baseline to Day 14
Thromboelastography (TEG) R time, reflecting the rate of initial fibrin formation, and K time, reflecting the kinetics of clot strengthening, performed on citrated whole blood at baseline and on Day 14, both reported in minutes; each parameter analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in Thromboelastography (TEG) Alpha Angle from Baseline to Day 14
Thromboelastography (TEG) alpha angle, reflecting the speed of fibrin build-up and thrombin activity, performed on citrated whole blood at baseline and on Day 14, reported in degrees; analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in Thromboelastography (TEG) Maximum Amplitude (MA) from Baseline to Day 14
Thromboelastography (TEG) maximum amplitude (MA), reflecting the strength of the platelet-fibrin clot and overall platelet function, performed on citrated whole blood at baseline and on Day 14, reported in millimeters; analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in Thrombomodulin (TM), Thrombin-Antithrombin Complex (TAT), and ICAM-1 from Baseline to Day 14
Plasma thrombomodulin (TM), thrombin-antithrombin complex (TAT), and intercellular adhesion molecule-1 (ICAM-1) measured in venous blood samples at baseline and on Day 14, all reported in ng/mL; each analyte analyzed as change from baseline. TAT reflects in vivo thrombin generation, while TM and ICAM-1 reflect endothelial injury and activation.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in von Willebrand Factor (VWF) from Baseline to Day 14
Plasma von Willebrand factor (VWF), an established marker of endothelial activation that mediates platelet adhesion, measured in venous blood samples at baseline and on Day 14, reported in IU/dL; analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in Endothelin-1 (ET-1) and Angiopoietin-2 (ANG-2) from Baseline to Day 14
Plasma endothelin-1 (ET-1) and angiopoietin-2 (ANG-2) measured in venous blood samples at baseline and on Day 14, both reported in pg/mL; each analyte analyzed as change from baseline. Both markers reflect endothelial dysfunction and vascular permeability.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in Platelet Aggregation Rate and Platelet Adhesion Rate from Baseline to Day 14
ADP-induced and collagen-induced platelet aggregation rates and the platelet adhesion rate, measured in blood samples at baseline and on Day 14, all reported as percentages; each measure analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in Platelet Surface P-selectin (CD62P) from Baseline to Day 14
Platelet surface P-selectin (CD62P) expression, reported as percent mean fluorescence intensity (MFI) by flow cytometry, measured at baseline and on Day 14; analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in Platelet Factor 4 (PF4) from Baseline to Day 14
Plasma platelet factor 4 (PF4), a marker of platelet activation, measured in venous blood samples at baseline and on Day 14, reported in ng/mL; analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in GP IIb/IIIa Receptor Activity, GP Ib Receptor Expression, and VWF-Platelet Binding Capacity from Baseline to Day 14
Glycoprotein IIb/IIIa receptor activity, glycoprotein Ib receptor expression, and the VWF-platelet binding capacity (binding index), measured in blood samples at baseline and on Day 14, all reported as percentages; each measure analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in Mean Platelet Volume (MPV) from Baseline to Day 14
Mean platelet volume (MPV), a marker of platelet activation and thrombopoiesis, measured in venous blood samples at baseline and on Day 14, reported in fL; analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in Platelet Distribution Width (PDW) and Immature Platelet Fraction (IPF) from Baseline to Day 14
Platelet distribution width (PDW) and immature platelet fraction (IPF), measured in venous blood samples at baseline and on Day 14, both reported as percentages; each analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in White Blood Cell Count (WBC) from Baseline to Day 14
White blood cell count measured in venous blood samples collected at each protocol-specified time point, reported as 10\^9/L; analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14
Change in C-reactive Protein (CRP) from Baseline to Day 14
Serum C-reactive protein (CRP), a sensitive systemic inflammation marker in sepsis, measured at each protocol-specified time point, reported in mg/L; analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14
Change in Procalcitonin (PCT) from Baseline to Day 14
Serum procalcitonin (PCT), used to gauge bacterial infection burden and sepsis severity, measured at each protocol-specified time point, reported in ng/mL; analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14
Change in Cytokines IL-2 Receptor, IL-1β, IL-8, and IL-10 from Baseline to Day 14
Plasma interleukin-2 receptor, interleukin-1 beta (IL-1β), interleukin-8 (IL-8), and interleukin-10 (IL-10) measured in venous blood samples at baseline and on Day 14, reported in ug/L; each cytokine analyzed as change from baseline. These represent the pro-inflammatory and anti-inflammatory arms of the cytokine response.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in Interleukin-6 (IL-6) from Baseline to Day 14
Plasma interleukin-6 (IL-6), a central pro-inflammatory cytokine linking inflammation and coagulation activation, measured in venous blood samples at baseline and on Day 14, reported in ng/L; analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Change in Tumor Necrosis Factor-alpha (TNF-α) from Baseline to Day 14
Plasma tumor necrosis factor-alpha (TNF-α) measured in venous blood samples at baseline and on Day 14, reported in pg/mL; analyzed as change from baseline.
Time frame: From baseline through Day 14, assessed on Days 0 and 14
Number of days of organ function support (vasopressors, mechanical ventilation, or renal replacement therapy)
Number of days receiving organ function support, including vasopressors, mechanical ventilation, and renal replacement therapy, counted for all randomized participants from randomization; each support type analyzed separately.
Time frame: From randomization to hospital discharge or through study completion, an average of approximately 22 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
All adverse events, serious adverse events, and adverse reactions, with particular attention to bleeding events and allergic reactions, monitored at every protocol-specified visit through Day 28. Causality is assessed on a five-point scale (definitely related, probably related, potentially related, probably not related, or unrelated); treatment-related adverse events are those assessed as definitely, probably, or potentially related to the study intervention. Severity is graded according to NCI-CTCAE v4.0.
Time frame: From first dose through Day 28
Plan to share: No
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