Can an ancient herbal pill improve outcomes after a bleeding stroke?
NCT ID NCT07752719
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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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.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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