Sponsor study identifier
Secondary identifiers
OTHER · Ethics Committee of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
interventional
210
1 country
1
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
July 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 12, 2026
Actual (reported)October 27, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
From baseline (before the first dose) through Day 14
Change in ISTH-DIC score from baseline to Day 14
From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14
All-cause mortality at 28 days
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.
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.
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.
Emergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Li Ma, MD, PhD
Emergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
First Submitted
October 12, 2026
First Posted
October 27, 2026
The Effect of CUGP Fluid Management in Patients With Sepsis or Septic Shock
28 days after randomization
ICU length of stay and total hospital length of stay
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
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
From baseline through Day 14, assessed on Days 0, 1, 2, 3, 5, 7, and 14
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
From first dose through Day 28
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.
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.
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.
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Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
July 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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