NCT07240467Not yet recruitingPhase 2/3
Bovis Calculus Stativus Treat Acute Cerebral Ischemic Stroke With Impaired Consciousness
Safety and Efficacy of Bovis Calculus Stativus in the Treatment of Acute Cerebral Ischemic Stroke With Impaired Consciousness- A Multicenter, Prospective, Double-blind, Randomized Trial
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
Acute ischemic stroke (AIS) is a severe and life-threatening condition, with 35% of AIS patients experiencing impaired consciousness upon admission within 24 hours of onset. Previous studies indicated that patients with impaired consciousness at the onset of stroke have a higher incidence of stroke-related complications, particularly cerebral edema and pneumonia, as well as higher in-hospital and three-month mortality rates. The etiology of impaired consciousness in AIS is complex: ischemic damage to reticular activating system of the brainstem can directly lead to cell necrosis and result in impaired consciousness. Furthermore, secondary pathological changes following AIS, such as excitatory amino acid toxicity, oxidative stress, free radical production, and cascading inflammatory responses, can indirectly worsen impaired consciousness. Therefore, impaired consciousness at the onset of AIS is the result of cellular damage under multiple pathophysiological mechanisms. Developing neuroprotective drugs with multiple targets is key to effectively improving adverse outcomes related to impaired consciousness in AIS. However, there is currently a lack of treatment specifically aimed at improving impaired consciousness at the onset of AIS. Cultivated Bovine Bezoar (Bovis Calculus Stativus, BCS) combines the advantages of pharmacological similarity to natural bovine by adding components such as deoxycholic acid, cholic acid, and composite calcium bilirubin to fresh bovine bile. It is rich in various trace elements and amino acids and is a compound medication that can exert neuroprotective effects through multiple pathways and targets. In traditional Chinese medicine, it has long been used to treat various consciousness disorder-related diseases, including stroke. The various components of in vitro cultivated bezoar are also widely used in clinical research for various neurological diseases.The above evidence fully demonstrates that BCS is an optimal treatment for impaired consciousness in stroke. The goal of this clinical trial is to learn if Bovis Calculus Stativus works to treat acute cerebral ischemic stroke with impaired consciousness. It will also learn about the safety of Bovis Calculus Stativus. The main questions it aims to answer are: 1. Does Bovis Calculus Stativus treat and alleviate consciousness disorders in patients with acute cerebral infarction accompanied by impaired consciousness ？ 2. What medical problems do participants have when taking Bovis Calculus Stativus? Researchers will compare Bovis Calculus Stativus to a placebo (a look-alike substance that contains no drug) to see if Bovis Calculus Stativus works to treat acute cerebral ischemic stroke with impaired consciousness. Participants will: 1. receive treatment with Bovis Calculus Stativus (or placebo) for 5 days. 2. Take an in-person or telephone follow-up within 90 days after the acute stroke.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 16 Nov 2025
- Start date
- 15 Dec 2025
- Primary completion date
- 15 Dec 2028
- Lead sponsor
- Xiang Luo
- Diseases
- Stroke
- NCT number
- NCT07240467
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 220
- From 15 Dec 2025 to the primary completion date, 15 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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);
- Expected survival time less than 6 months (e.g., due to malignancy, severe cardiopulmonary disease, etc.);
- 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).
Lab values
- Requiring or undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency (glomerular filtration rate \<30 mL/min or serum creatinine \>220 μmol/L);
Other
- Use of in BCS within 24 hours before treatment;
- Known pregnancy or breastfeeding, or positive pregnancy test before randomization;
- Participation in other interventional clinical studies that may affect outcome assessment;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.