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Safflower (Carthamus Tinctorius L.) Granules for Sepsis-associated Coagulopathy
Sponsor: Shanghai Jiao Tong University School of Medicine
Summary
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.
Official title: Efficacy of Safflower (Carthamus Tinctorius L.) Granules in Patients With Sepsis-associated Coagulopathy: a Randomized, Double-blind, Controlled, Three-arm Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2026-11-01
Completion Date
2028-08-31
Last Updated
2026-10-27
Healthy Volunteers
No
Interventions
High-dose safflower granules
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.
Medium-dose safflower 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.
Placebo granules (one-tenth of medium-dose safflower)
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.
Locations (1)
Emergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China