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Can an ancient herbal pill improve outcomes after a bleeding stroke?

NCT ID NCT07752719

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This phase 3 trial is testing whether Angong Niuhuang, a traditional Chinese medicine, can improve recovery in people who have had a bleeding stroke (intracerebral hemorrhage). About 1,100 adults who are eligible for non-surgical management will receive either the herbal pill or a placebo, in addition to standard care, starting as soon as possible after the stroke and continuing for 14 days. The main goal is to see if the treatment reduces long-term disability, measured by the modified Rankin Scale, compared to placebo.

What this could mean

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

Active substance
Angong Niuhuang pills (ANP), a traditional Chinese medicine, given alongside standard care
What this could lead to
If effective, this could offer a new, widely accessible add-on treatment to improve functional recovery and reduce disability after a bleeding stroke.
What could go wrong
This is a large trial, but the treatment is an unproven traditional remedy; it may not outperform placebo, and there are risks of adverse effects or interactions with standard stroke care.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,100 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

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 * In-Hospital Setting 1. Age ≥18 years. 2. Symptom onset or last known well ≤6 hours before randomization. Intracerebral hemorrhage (ICH) confirmed by brain imaging, with a hematoma volume ≥10 mL. 3. National Institutes of Health Stroke Scale (NIHSS) score ≥8. 4. Glasgow Coma Scale (GCS) score ≥8. 5. Traditional Chinese medicine (TCM) syndrome consistent with internal accumulation of heat-toxin, defined by the presence of at least 2 of the following: high fever, facial flushing, agitation, dry mouth, and rapid pulse. 6. No surgery performed at the time of randomization. 7. Written informed consent obtained from the participant or their legally authorized representative. * Prehospital (Ambulance) Setting 1. Age ≥18 years. 2. Symptom onset or last known well ≤6 hours before randomization. 3. Predicted to have ICH by an artificial intelligence-based model. 4. FAST score ≥2. 5. TCM syndrome consistent with internal accumulation of heat-toxin, defined by the presence of at least 2 of the following: high fever, facial flushing, agitation, dry mouth, and rapid pulse. 6. Written informed consent obtained from the participant or their legally authorized representative. Exclusion Criteria * In-Hospital Setting 1. Secondary ICH, including ICH associated with cerebrovascular malformations or other structural abnormalities, brain tumors, head trauma, hemorrhagic transformation of cerebral infarction, or bleeding following thrombolysis or thrombectomy. 2. Severe comorbidities that may interfere with study treatment, follow-up, or outcome assessment (e.g., severe heart failure, malignant tumors, chronic obstructive pulmonary disease, or severe pre-existing disability). 3. Known allergy to Angong Niuhuang Wan or any of its ingredients. 4. Pregnancy or breastfeeding. 5. History of severe chronic kidney disease or hepatic failure. 6. Very high likelihood of death within 7 days or poor anticipated adherence to study treatment or follow-up. * Prehospital (Ambulance) Setting 1. Blood glucose \<2.8 mmol/L. 2. History of head trauma within the previous 7 days. 3. History of seizures or seizure-like episodes. 4. Severe comorbidities that may interfere with study treatment, follow-up, or outcome assessment (e.g., severe heart failure, malignant tumors, chronic obstructive pulmonary disease, or severe pre-existing disability). 5. Known allergy to Angong Niuhuang Wan or any of its ingredients. 6. Pregnancy or breastfeeding. 7. History of severe chronic kidney disease or hepatic failure. 8. Very high likelihood of death within 7 days or poor anticipated adherence to study treatment or follow-up.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The official record

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