Investigating the Clinical Benefits and Underlying Mechanisms of Danhong Injection in Modulating Mitochondrial Homeostasis Against Sepsis-Associated Myocardial Dysfunction
NCT07375862 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2026-01-29
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
- 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.
Sponsors & Collaborators
-
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-01
- Primary Completion
- 2028-12-01
- Completion
- 2028-12-01
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