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Herbal injection could shield hearts during sepsis

NCT ID NCT07375862

Disease control Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a herbal medicine called Danhong injection can help protect the heart in people with sepsis, a life-threatening infection. Researchers will give 140 patients either the injection or a placebo for 7 days and check heart function and survival rates. The goal is to see if this treatment reduces heart damage and improves outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Danhong injection (herbal extract given intravenously)
What this could lead to
If it works, this could point toward a new treatment to protect the heart during severe infections like sepsis.
What could go wrong
This is an early Phase 2 trial with only 140 people, so results may not apply widely. The herbal injection may not improve heart function or survival compared to placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

bacterial myocarditis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sepsis induced myocardial dysfunction

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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