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

January 22, 2026 updated by: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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. Exclusion criteria included long-term use of Danhong Injection or recent use of other medication with potential significant impact on cardiac function.
  3. Patients with severe hepatic dysfunction (defined as Child-Pugh class C) or severe renal insufficiency (defined as creatinine clearance <30 mL/min) were excluded.
  4. Patients with a known allergy to any component of Danhong Injection or a history of severe allergic diathesis were excluded.
  5. Pregnant or lactating women
  6. Patients with severe mental illness or inability to cooperate with the study.
  7. Participation in other drug clinical trials within 3 months prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Drug: Saline
Intravenous drip of 100 ml 0.9% saline solution, twice daily, for 7 consecutive days.
Experimental: Danhong Injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left Ventricular Ejection Fraction
Time Frame: 24 hours before treatment, 3 days after treatment
24 hours before treatment, 3 days after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2025-313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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