Ancient remedy tested for Stroke-Induced coma: could cultivated bezoar wake patients?
NCT ID NCT07240467
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a traditional Chinese medicine called Bovis Calculus Stativus (cultivated bezoar) in 220 adults who had a stroke and are now unconscious or barely responsive. Participants receive either the medicine or a placebo for 5 days, and are followed for 90 days. The goal is to see if the medicine safely helps improve consciousness and overall recovery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 220 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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: * Age ≥ 18 years; * Clinically diagnosed with ischemic cerebral infarction; * GCS score: 3-12; * Time from symptom onset to randomization ≤ 24 hours, including wake-up stroke or stroke without a witness; the time of symptom onset is defined as the "last known well time"; * Pre-stroke mRS score of 0-1; * Head CT excludes intracranial hemorrhage or other non-ischemic pathologies; * The participant or legally authorized representative is capable of providing informed consent. Exclusion Criteria: * Use of in BCS within 24 hours before treatment; * Known pregnancy or breastfeeding, or positive pregnancy test before randomization; * Allergy to BCS; * Impaired consciousness caused by other diseases, such as metabolic disorders (e.g., ketoacidosis), trauma, infectious diseases (e.g., pneumonia), neoplastic diseases (e.g., glioma), or toxic conditions (e.g., organophosphate poisoning); * Requiring or undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency (glomerular filtration rate \<30 mL/min or serum creatinine \>220 μmol/L); * Expected survival time less than 6 months (e.g., due to malignancy, severe cardiopulmonary disease, etc.); * Participation in other interventional clinical studies that may affect outcome assessment; * Other conditions deemed by the investigator to make the patient unsuitable for participation or pose significant risks (e.g., inability to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorders).
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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
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Other studies related to the condition(s) this trial covers.
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