Acute Ischemic Stroke AISPhase 2/3ASCENT-BCNCT07240467
Bovis Calculus Stativus Treat Acute Cerebral Ischemic Stroke With Impaired Consciousness
A Phase 2/3 study testing Bovis Calculus Stativus (BCS) in people with Acute Ischemic Stroke AIS and Impaired Consciousness, run by Xiang Luo.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke AIS, Impaired Consciousness
- What is being tested?
- Bovis Calculus Stativus (BCS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 15 Dec 2028
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read more
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:
- Does Bovis Calculus Stativus treat and alleviate consciousness disorders in patients with acute cerebral infarction accompanied by impaired consciousness ？
- 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:
- receive treatment with Bovis Calculus Stativus (or placebo) for 5 days.
- Take an in-person or telephone follow-up within 90 days after the acute stroke.
Read the detailed description
This study evaluates whether the combination of Bovis Calculus Stativus (BCS) with conventional treatment can improve impaired consciousness and functional outcomes, and whether it increases serious adverse events in patients with acute cerebral infarction accompanied by impaired consciousness within 72 hours of onset. This is a prospective multicenter randomized controlled double-blind study. In 12 centers in China,220 patients with the following situations will be enrolled: acute ischemic stroke accompanied by impaired consciousness within 72 hours and a GCS score of 3-12. Patients will be randomly assigned into 2 groups according to the ratio of 1:1:
- Experimental Group: 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.
- Placebo Control Group:
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 immediately 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.
Patients will be assessed using the GCS and NIHSS scores at 24 hours and 8 days after randomization, and the mRS score at 8 days after randomization. A follow-up visit, either in person or via telephone, will be conducted 90 days after randomization to assess the mRS and EQ-5D-5L scores.
- Conditions
- Acute Ischemic Stroke AIS, Impaired Consciousness
- Being tested
- Bovis Calculus Stativus (BCS), Placebo
- Keywords
- acute ischemic stroke, impaired consciousness, Bovis Calculus Stativus
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovis Calculus Stativus (BCS)Drug
Also called trade: Bovis Calculus Stativus (BCS);Wuhan Jianmin Dapeng Pharmaceutical Co., Ltd.
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 8 after randomization
Secondary outcomes (5)
GCS shift analysis
GCS score overall shift assessment of consciousness disturbance overall improvement ratio
Measured: Day 8 after randomization
Proportion of mRS 0-2
Proportion of overall favorable prognosis
Measured: Day 90 after randomization
Proportion of NIHSS score 0-1 or a reduction of ≥4 points from baseline
Proportion of good neurological function recovery
Measured: Day 8 after randomization
EQ-5D-5L index score
The EQ-5D-5L index score is a single summary number that represents a person's overall health state based on the EQ-5D-5L descriptive system. It's a crucial tool for calculating Quality-Adjusted Life Years (QALYs) used in health economics and outcomes research.The five levels are:
- Level 1: No problems
- Level 2: Slight problems
- Level 3: Moderate problems
- Level 4: Severe problems
- Level 5: Extreme problems / Unable to
Measured: Day 90 after randomization
In-hospital stroke-associated pneumonia incidence rate
Proportion of Hospital-Acquired Pneumonia Complications
Measured: Day 8 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic Stroke AISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiang Luo
- Sponsor type
- University, hospital or other
- Collaborators
- The Fifth Hospital of Wuhan, Jingzhou Hospital of Traditional Chinese Medicine, Xiangyang Hospital of Traditional Chinese Medicine, Wuhan Hospital of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Wuhan No.1 Hospital, Wuhan Central Hospital, Xiangyang No.1 People's Hospital, Taihe Hospital affiliated to Hubei University of Medicine, Yichang Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Xiang Luo, Tongji Hospital
- Investigators
- Xiang Luo, PhD MD, Principal investigator, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 450001Xiang Luo, PhD MD, Principal investigator, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240467
- Sponsor's protocol ID
- 20250712
- Acronym
- ASCENT-BC
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25587341