Investigating the Clinical Benefits and Underlying Mechanisms of Danhong Injection in Modulating … (NCT07375862) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Investigating the Clinical Benefits and Underlying Mechanisms of Danhong Injection in Modulating Mitochondrial Homeostasis Against Sepsis-Associated Myocardial Dysfunction
140 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Patients with a diagnosis of sepsis-induced myocardial dysfunction (SIMD).
Exclusion criteria
. Patients with significant primary cardiac diseases, including unstable coronary artery disease, severe cardiomyopathy, or severe valvular heart disease.
. Exclusion criteria included long-term use of Danhong Injection or recent use of other medication with potential significant impact on cardiac function.
. Patients with severe hepatic dysfunction (defined as Child-Pugh class C) or severe renal insufficiency (defined as creatinine clearance \<30 mL/min) were excluded.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Left Ventricular Ejection Fraction
Timeframe: 24 hours before treatment, 3 days after treatment
Trial details
NCT IDNCT07375862
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine