Efficacy and Safety of Calculus Bovis Sativus (CBS) for Intracerebral Hemorrhage(CBSinICH)

NCT07080632 | Not Yet Recruiting

• 1 other identifier: CBSinICH
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The most common cause of death for Chinese patients is intracerebral hemorrhage(ICH), particularly cerebral infarction. It places a heavy burden on people, families, and society as a whole and poses considerable risks of death and disability. The disease is difficult to identify, and is frequently detected only after it progresses to the point of vascular cognitive dysfunction. The primary ischemia necrosis of brain nerve cells and the activation of inflammatory cells are their pathologic processes. According to historical Chinese medical documents, bezoar possesses properties that can help prevent seizures, treat strokes, enhance cognitive function and mental well-being, and stimulate alertness. Calculus Bovis Sativus (CBS) is the most authentic formulation of bezoar ingredients compared to other bezoar products. It has received approval from the China Food and Drug Administration for the essential treatment of comatose patients. CBS consists of three primary constituents: bilirubin, bile acids, and taurine. Scientific evidence has demonstrated that all of these components possess anti-inflammatory, antioxidant, and neuroprotective properties. The investigators' objective is to carry out an investigator-initiated clinical study to assess the efficacy of orally administered CBS in treating intracerebral hemorrhag diseases in humans.

Conditions

Intracerebral Hemorrhage; Brain Hemorrhage

Keywords

calculus bovis sativus; Neuroprotection; Neuroinflammation

Outcome Measures

Primary Outcomes (3)

• The Modified Rankin Scale (mRS)

  To assess mRS of subjects within 12 weeks after treatment initiation. The score ranges from 0 to 5. 5 represents the worst.

  Up to 12 weeks after treatment initiation

• National Institute of Health stroke scale (NIHSS)

  To assess NIHSS of subjects within 12 weeks after treatment initiation. The score ranges from 0 to 42 represents the worst.

  Up to 12 weeks after treatment initiation

• Incidence and Severity of Adverse Effects (AEs) and Severe Adverse Effects (SAEs)

  To evaluate the AEs and SAEs occurred within 14 weeks after treatment initiation

  Up to 14 weeks after treatment initiation

Secondary Outcomes (7)

• Qualitative and quantitative assessment of changes in white matter fiber tracts via brain DTI at Week 12 compared to baseline (Visit 1) and the control group

  Up to 12 weeks after treatment initiation

• The score of Mini-mental State Examination (MMSE) at week 12 compared with baseline (visit 1) and control group.

  Up to 12 weeks after treatment initiation

• Montreal cognitive assessment scale (MoCA) at week 12 compared with baseline (visit 1) and control group.

  Up to 12 weeks after treatment initiation

• The score of Hamilton Anxiety Scale at week 12 compared with baseline (visit 1) and control group.

  Up to 12 weeks after treatment initiation

• The score of Hamilton Depression Scale at week 12 compared with baseline (visit 1) and control group

  Up to 12 weeks after treatment initiation

Other Outcomes (4)

• Qualitative and quantitative changes in MRI（QSM、CEST、DKI） findings at week 12 compared to baseline (Visit 1).

  Up to 12 weeks after treatment initiation

• Comparison of fecal 16S rRNA sequencing gut microbiota profiles between week 12 and baseline (Visit 1)

  Up to 12 weeks after treatment initiation

• Comparative analysis of hemorrhagic stress response biomarkers (e.g., inflammatory mediators) in fecal metabolomics between Week 12 and baseline (Visit 1)

  Up to 12 weeks after treatment initiation

Study Arms (2)

CBS therapy, CBS dosage: 300mg per day from day 1 to day 7, in ICH cohort

EXPERIMENTAL

Subjects in ICH cohort of this arm will receive general therapy plus CBS.

Drug: Calculus bovis sativus (CBS)

NCB therapy,NCB dosage: 300mg per day from day 1 to day 7, in ICH cohort

EXPERIMENTAL

Subjects in ICH cohort of this arm will receive general therapy plus NCB.

Drug: Natural Calculus Bovis(NCB)

Interventions

Calculus bovis sativus (CBS) DRUG

Subjects will orally receive 300mg CBS per day from day 1 to day 7

CBS therapy, CBS dosage: 300mg per day from day 1 to day 7, in ICH cohort

Natural Calculus Bovis(NCB) DRUG

Subjects will orally receive 300mg NCB per day from day 1 to day 7

NCB therapy,NCB dosage: 300mg per day from day 1 to day 7, in ICH cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject and/or their legal guardian(s) must have full legal capacity, fully understand the purpose, significance, methodology, potential risks, possible adverse effects, types of personal data collected, scope of use, processing methods, retention period, and other relevant information regarding this study. Consent must be given voluntarily.This study will strictly comply with the Personal Information Protection Law, Data Security Law, and other applicable laws/regulations, implementing necessary measures to ensure data security and prevent leakage, tampering, or loss.Upon consent, subjects/guardians authorize the research institution to lawfully process relevant health data, including but not limited to storage, analysis, and statistical use.The institution will strictly limit the scope of personal data usage; no additional purposes will be pursued without separate consent.Subjects/guardians retain the right to access, copy, correct, or delete their data, withdraw consent, or request explanations from the institution.All personal data processing will adhere to legal requirements, ensuring legitimacy, justification, and necessity.
• Male or female, aged 18-80 years (inclusive) at the time of providing informed nsent.
• All sexually active participants (male and female of reproductive potential) must use effective contraception during the study and for at least 6 months after the last dose of the investigational treatment.Participants must not donate sperm or eggs during the study or for 6 months post-treatment.
• Confirmed diagnosis meeting the following criteria:
• Hypertensive ICH per Diagnostic Criteria for Spontaneous Intracerebral Hemorrhage in Adults , verified by cranial CT.
• Traditional Chinese Medicine (TCM) diagnostic criteria (per Stroke Diagnosis and Efficacy Evaluation Standards by the National TCM Administration's Emergency Research Collaboration Group for Encephalopathy):Primary symptoms: Hemiplegia, impaired consciousness, slurred speech/mutism, sensory deficits, facial deviation.Secondary symptoms: Headache, dizziness, pupillary changes, dysphagia, gaze palsy, ataxia.Diagnosis: ≥2 primary symptoms or 1 primary + 2 secondary symptoms, combined with onset context, predisposing factors, prodromal signs, and age. Imaging may substitute for clinical criteria if insufficient.
• Hemorrhage volume: 5-10 mL.
• Clinical presentation: Impaired consciousness or significant neurological deficits.

You may not qualify if:

• Neurological examinations must demonstrate stability within 30 days prior to baseline (Visit 1).
• Medical History and Current Health Status
• Any clinically significant history of cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, renal, pulmonary, neurological, dermatologic, psychiatric, or other major diseases, as determined by the investigator, that would interfere with trial participation.
• Presence of any untreated intracranial tumor at baseline (randomization).
• Alternative causes of symptoms, including:Cerebral hemorrhage due to hematologic disorders or bleeding diathesis.Subarachnoid hemorrhage secondary to trauma.Vascular abnormalities (e.g., aneurysms, arteriovenous malformations).Traumatic brain injury, CNS infections, septic encephalopathy, metabolic encephalopathy, epileptic disorders, mitochondrial diseases, Klein-Levin syndrome, Creutzfeldt-Jakob disease, rheumatologic disorders, Reyes syndrome, or inborn metabolic errors.
• Any major surgery within 4 weeks before baseline, excluding:
• Planned surgery during the study (except minor procedures).
• History of severe allergies/anaphylaxis or any hypersensitivity reaction that may be exacerbated by study treatment components.
• Current or history of malignancy (including solid tumors and hematologic malignancies), except:Basal cell/squamous cell carcinoma fully excised and cured ≥12 months before screening.Subjects with cancer in remission for \>5 years may be included after sponsor approval.
• History of gastrointestinal surgery (except appendectomy/cholecystectomy \>6 months before screening), irritable bowel syndrome, inflammatory bowel disease (Crohn's, ulcerative colitis), or other clinically significant active GI disorders.
• Clinically significant recurrent/active GI symptoms (e.g., nausea, diarrhea, dyspepsia, constipation) within 90 days before screening, requiring:
• New symptomatic treatment (e.g., GERD medication initiation) or dose adjustments within 90 days.
• History of diverticulitis or severe GI abnormalities (e.g., symptomatic diverticulosis) that may increase risks (e.g., perforation).
• Blood/plasma/platelet donation (≥1 unit) within 90 days before screening.
• Active suicidal ideation within 6 months or suicide attempt within 3 years before screening.

Sponsors & Collaborators

• Tongji Hospital: lead
• Jianmin Pharmaceutical Group Co., LTD.: collaborator

Study Sites (1)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei 430000

Hubei, China

Location

Related Publications (23)

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MeSH Terms

Conditions

Cerebral Hemorrhage; Intracranial Hemorrhages; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation

Central Study Contacts

Qiang Zhang, MD

CONTACT

+8615827166616; zhangqiang_glia@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, President of Tongji Hospital

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 23, 2025
• Study Start: October 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)