Efficacy and Safety of Calculus Bovis Sativus (CBS) for Intracerebral Hemorrhage(CBSinICH)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTongji Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Hypertensive ICH per Diagnostic Criteria for Spontaneous Intracerebral Hemorrhage in Adults , verified by cranial CT.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Calculus bovis sativus (CBS)
DrugSubjects will orally receive 300mg CBS per day from day 1 to day 7
Natural Calculus Bovis(NCB)
DrugSubjects will orally receive 300mg NCB per day from day 1 to day 7
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: CBS therapy, CBS dosage: 300mg per day from day 1 to day 7, in ICH cohortExperimental treatment 1 intervention
Group B: NCB therapy,NCB dosage: 300mg per day from day 1 to day 7, in ICH cohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 12 weeks after treatment initiation2
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.
Time frame
Up to 12 weeks after treatment initiation3
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
Time frame
Up to 14 weeks after treatment initiationSecondary outcomes
1
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
Time frame
Up to 12 weeks after treatment initiation2
The score of Mini-mental State Examination (MMSE) at week 12 compared with baseline (visit 1) and control group.
The score of MMSE ranges from 0 to 30, and 30 represents the best
Time frame
Up to 12 weeks after treatment initiation3
Montreal cognitive assessment scale (MoCA) at week 12 compared with baseline (visit 1) and control group.
The score of MoCA ranges from 0 to 30, and 30 represents the best.
Time frame
Up to 12 weeks after treatment initiation4
The score of Hamilton Anxiety Scale at week 12 compared with baseline (visit 1) and control group.
The score of Hamilton Anxiety Scale ranges from 0 to 56, and 56 represents the worst
Time frame
Up to 12 weeks after treatment initiationOther outcomes
1
Qualitative and quantitative changes in MRI（QSM、CEST、DKI） findings at week 12 compared to baseline (Visit 1).
Time frame
Up to 12 weeks after treatment initiation2
Comparison of fecal 16S rRNA sequencing gut microbiota profiles between week 12 and baseline (Visit 1)
Time frame
Up to 12 weeks after treatment initiation3
Comparative analysis of hemorrhagic stress response biomarkers (e.g., inflammatory mediators) in fecal metabolomics between Week 12 and baseline (Visit 1)
Time frame
Up to 12 weeks after treatment initiation4
Profiling of lymphocytes subtypes in serum, including absolute counting and ratio of each type of lymphocyte, at week 12 compared with baseline (visit 1)
Time frame
Up to 12 weeks after treatment initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tongji Hospital
Lead sponsor
Jianmin Pharmaceutical Group Co., LTD.
Collaborator
Source ClinicalTrials.gov
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