Bovis Calculus Stativus Treat Acute Cerebral Ischemic Stroke With Impaired Consciousness

NCT07240467 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 20250712
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.Does Bovis Calculus Stativus treat and alleviate consciousness disorders in patients with acute cerebral infarction accompanied by impaired consciousness ？
2. 2.What medical problems do participants have when taking Bovis Calculus Stativus?
3. 3.receive treatment with Bovis Calculus Stativus (or placebo) for 5 days.
4. 4.Take an in-person or telephone follow-up within 90 days after the acute stroke.

Conditions

Impaired Consciousness; Acute Ischemic Stroke AIS

Keywords

acute ischemic stroke; impaired consciousness; Bovis Calculus Stativus

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with GCS improvement ≥2 points

  Proportion of patients with a GCS score increase of 2 points or more to assess the improvement rate of impaired consciousness

  Day 8 after randomization

Secondary Outcomes (5)

• GCS shift analysis

  Day 8 after randomization

• Proportion of mRS 0-2

  Day 90 after randomization

• Proportion of NIHSS score 0-1 or a reduction of ≥4 points from baseline

  Day 8 after randomization

• EQ-5D-5L index score

  Day 90 after randomization

• In-hospital stroke-associated pneumonia incidence rate

  Day 8 after randomization

Other Outcomes (2)

• The incidence of SAE

  Day 8 after randomization

• All-cause mortality

  Day 8 after randomization

Study Arms (2)

Bovis Calculus Stativus (BCS) group

EXPERIMENTAL

Patients with acute ischemic stroke accompanied by impaired consciousness within 72 hours and a Glasgow Coma Scale (GCS) score of 3-12, who are randomized to the experimental group, will be administered 0.6 g of BCS orally or via nasogastric tube immediately after recruitment. Subsequently, in accordance with guidelines, they will receive standard acute stroke treatment along with 0.6 g of BCS twice daily (bid) orally or via nasogastric tube for 5 consecutive days.

Drug: Bovis Calculus Stativus (BCS)

placebo group

PLACEBO COMPARATOR

Patients with acute ischemic stroke accompanied by impaired consciousness within 72 hours and a GCS score of 3-12, who are randomized to the control group, will be administered a placebo following the same regimen after recruitment. Subsequently, in accordance with guidelines, they will receive standard acute stroke treatment along with the placebo administered orally or via nasogastric tube for 5 consecutive days.

Drug: Placebo

Interventions

Bovis Calculus Stativus (BCS) DRUG

Patients with acute ischemic stroke accompanied by impaired consciousness within 72 hours and a Glasgow Coma Scale (GCS) score of 3-12, who are randomized to the experimental group, will be administered 0.6 g of BCS orally or via nasogastric tube immediately in the emergency room. Subsequently, in accordance with guidelines, they will receive standard acute stroke treatment along with 0.6 g of BCS twice daily (bid) orally or via nasogastric tube for 5 consecutive days.

Also known as: trade: Bovis Calculus Stativus (BCS);Wuhan Jianmin Dapeng Pharmaceutical Co., Ltd.

Bovis Calculus Stativus (BCS) group

Placebo DRUG

Patients with acute ischemic stroke accompanied by impaired consciousness within 72 hours and a GCS score of 3-12, who are randomized to the control group, will be administered a placebo following the same regimen in the emergency room. Subsequently, in accordance with guidelines, they will receive standard acute stroke treatment along with the placebo administered orally or via nasogastric tube for 5 consecutive days.

placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Taihe Hospital affiliated to Hubei University of Medicine: collaborator
• Xiang Luo: lead
• The Fifth Hospital of Wuhan: collaborator
• Jingzhou Hospital of Traditional Chinese Medicine: collaborator
• Xiangyang Hospital of Traditional Chinese Medicine: collaborator
• Wuhan Hospital of Traditional Chinese Medicine: collaborator
• Hubei Hospital of Traditional Chinese Medicine: collaborator
• Wuhan No.1 Hospital: collaborator
• Wuhan Central Hospital: collaborator
• Xiangyang No.1 People's Hospital: collaborator
• Yichang Hospital of Traditional Chinese Medicine: collaborator

Related Publications (1)

• Guo Y, Yan S, Xu L, Zhu G, Yu X, Tong X. Use of angong niuhuang in treating central nervous system diseases and related research. Evid Based Complement Alternat Med. 2014;2014:346918. doi: 10.1155/2014/346918. Epub 2014 Dec 18.

  PMID: 25587341 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Xiang Luo, PhD MD

  Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 450001

  PRINCIPAL INVESTIGATOR

• Xiang Luo, PhD MD

  Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Luo, PhD, MD

CONTACT

13349893413; flydottjh@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 21, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share