NCT07375862

Investigating the Clinical Benefits and Underlying Mechanisms of Danhong Injection in Modulating Mitochondrial Homeostasis Against Sepsis-Associated Myocardial Dysfunction

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the clinical efficacy of Danhong injection in patients with septic myocardial injury through a prospective randomized controlled trial. The study will enroll 140 patients meeting criteria for septic myocardial injury, divided into a Danhong injection group and a placebo group. Primary endpoints include changes in myocardial injury markers and improvement rates in cardiac function over 7 days, while secondary endpoints include 28-day mortality rates. This will determine whether Danhong injection possesses myocardial protective effects and provide evidence-based support for expanding its clinical indications.

Conditions

• Sepsis-Induced Myocardial Dysfunction

Interventions

Type	Name	Description
DRUG	Danhong injection	Danhong Injection for intravenous drip, dosage: 20 ml, diluted in 80 ml of 0.9% saline solution for intravenous drip, twice daily, for a continuous treatment period of 7 days.
DRUG	Saline	Intravenous drip of 100 ml 0.9% saline solution, twice daily, for 7 consecutive days.

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2026-01-29
• Last updated: 2026-01-29