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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07375862

Enrollment

140

Registered

2026-01-29

Start date

2026-07-01

Completion date

2028-12-01

Last updated

2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis-Induced Myocardial Dysfunction

Brief 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.

Interventions

DRUGDanhong 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.

DRUGSaline

Intravenous drip of 100 ml 0.9% saline solution, twice daily, for 7 consecutive days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients who met the Sepsis-3 criteria, defined by a suspected or confirmed infection and an increase in the Sequential Organ Failure Assessment (SOFA) score of 2 points or more from baseline. 2. Patients with a diagnosis of sepsis-induced myocardial dysfunction (SIMD).

Exclusion criteria

1. Patients with significant primary cardiac diseases, including unstable coronary artery disease, severe cardiomyopathy, or severe valvular heart disease. 2.

Design outcomes

Primary

Measure	Time frame
Left Ventricular Ejection Fraction	24 hours before treatment, 3 days after treatment

Secondary

Measure	Time frame
cardiac troponin T	Before treatment, 3 days after treatment, 7 days after treatment
28-day mortality	28 days after enrollment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026