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Intracerebral HemorrhageNCT07080632

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

A study testing Calculus bovis sativus (CBS) and Natural Calculus Bovis(NCB) in people with Intracerebral Hemorrhage and Brain Hemorrhage, run by Tongji Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Intracerebral Hemorrhage, Brain Hemorrhage
What is being tested?
Calculus bovis sativus (CBS) and Natural Calculus Bovis(NCB)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
1 Oct 2025to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Hemorrhage volume: 5-10 mL.
  • Clinical presentation: Impaired consciousness or significant neurological deficits.
  • Exclusion: No respiratory failure.
  • Neurological examinations must demonstrate stability within 30 days prior to baseline (Visit 1).

Who cannot join

  • 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:
  • Laparoscopic or minor procedures (defined as those requiring only local anesthesia/conscious sedation, performed outpatient; e.g., toenail surgery, mole excision, wisdom tooth extraction).Exclusion: Thymoma or teratoma resection.
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  • 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.
  • Clinically significant laboratory abnormalities per investigator judgment.
  • Pregnancy, lactation, or plans to conceive during the study or within 3 months post-treatment.
  • Women of childbearing potential must have negative serum/urine pregnancy tests at screening and pre-dose.
  • Physical/mental conditions compromising safety or efficacy assessments.
  • Screening/baseline systolic BP >150 mmHg or <90 mmHg after 5-minute rest (one repeat allowed; exclusion if persistent).
  • Within 3 months before screening:Second-/third-degree AV block, sick sinus syndrome, uncontrolled atrial fibrillation, severe/unstable angina, congestive heart failure, myocardial infarction, or major ECG abnormalities (QTc >450 ms [men] or >470 ms [women; Fridericia correction]).
  • Planned elective procedures/surgery after ICF signing.
  • Conditions impairing drug absorption (e.g., gastrectomy).
  • History of heparin allergy or heparin-induced thrombocytopenia.
  • Clinically relevant abnormalities in medical history, physical exam, ECG, or lab tests.
  • Infection Risk
  • HIV infection (positive test/history).
  • Active hepatitis C (HCV Ab+ with detectable HCV RNA).Allowed: HCV Ab+ with undetectable RNA.
  • Active hepatitis B (HBsAg+ and/or anti-HBc+).Allowed: Prior natural infection (HBsAg-/anti-HBc+/anti-HBs+) or vaccination (HBsAg-/anti-HBc-/anti-HBs+).
  • Chronic/severe/recurrent infections (e.g., pneumonia, sepsis) within 90 days before baseline.
  • TB diagnosis/latent TB (positive IGRA or 2 consecutive tests).
  • Bacterial/fungal/viral infection symptoms (including URI) within 28 days before baseline Re-screening permitted after successful treatment of localized fungal infections (e.g., candidiasis, tinea).
  • Infection requiring hospitalization/IV antibiotics within 4 weeks before baseline.
  • Live/attenuated vaccination within 28 days before baseline or planned during the study.
  • Contraindications to rescue therapies (rituximab, IVIG, high-dose corticosteroids, IV cyclophosphamide).
  • Prior treatments:Total lymphoid irradiation, cladribine, T-cell/TCR vaccines, stem cell transplant (any time).
  • Laboratory Values
  • Clinically significant abnormal lab results at screening/baseline (investigator discretion).
  • Hematologic abnormalities at screening:
  • WBC <3.0 × 10³/µL
  • ANC <2.0 × 10³/µL
  • Lymphocytes <0.5 × 10³/µL
  • Platelets <100 × 10³/µL
  • ALT/AST/GGT ≥3× ULN or bilirubin >2× ULN
  • eGFR ≤60 mL/min/1.73 m²
  • Lymphocytes <LLN
  • Urinalysis abnormalities at screening:
  • β-2-microglobulin >0.3 μg/mL
  • Albumin/creatinine ratio >22.6 mg/mmol
  • Other
  • Prior participation in this study.
  • Blood donation (≥1 unit) within 90 days, plasma within 1 week, or platelets within 6 weeks before screening.
  • Alcohol/drug abuse within the past year (investigator-determined).
  • Pregnancy, lactation, or plans to conceive/breastfeed during the study or within 30 days post-treatment.
  • Current or prior (within 90 days) participation in another clinical trial.
  • Clinically significant suicidal ideation/behavior within 12 months (per C-SSRS).
  • Inability/unwillingness to comply with protocol requirements.
  • Severe hearing/visual impairment, language barriers, claustrophobia, or other conditions preventing neuropsychological assessments/MRI.
  • Any other reason deemed by the investigator/sponsor to preclude enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qiang Zhang, MD contact

+8615827166616

zhangqiang_glia@126.com

China1 site

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

    Hubei

Other trials in China

About this study

Official title: An Open Label Clinical Trial to Evaluate the Efficacy and Safety of Calculus Bovis Sativus (CBS) for Intracerebral Hemorrhage

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.

Being tested
Calculus bovis sativus (CBS), Natural Calculus Bovis(NCB)
Keywords
calculus bovis sativus, Neuroprotection, Neuroinflammation
Medical subject headings
Cerebral Hemorrhage, Intracranial Hemorrhages, Neuroinflammatory Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calculus bovis sativus (CBS)Drug

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

  • Natural Calculus Bovis(NCB)Drug

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

Study groups in NCT07080632
Study groupRoleWhat they receive
CBS therapy, CBS dosage: 300mg per day from day 1 to day 7, in ICH cohortExperimentalSubjects in ICH cohort of this arm will receive general therapy plus CBS.
Receives: Drug: Calculus bovis sativus (CBS)
NCB therapy,NCB dosage: 300mg per day from day 1 to day 7, in ICH cohortExperimentalSubjects in ICH cohort of this arm will receive general therapy plus NCB.
Receives: Drug: Natural Calculus Bovis(NCB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 12 weeks after treatment initiation

  2. 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.

    Measured: Up to 12 weeks after treatment initiation

  3. 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

    Measured: Up to 14 weeks after treatment initiation

Secondary outcomes (7)

  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

    Measured: Up to 12 weeks after treatment initiation

  2. 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

    Measured: Up to 12 weeks after treatment initiation

  3. 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.

    Measured: Up to 12 weeks after treatment initiation

  4. 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

    Measured: Up to 12 weeks after treatment initiation

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

    The score of Hamilton Depression Scale ranges from 0 to 81, and 81 represents the worst

    Measured: Up to 12 weeks after treatment initiation

  6. The score of 36-item Short-Form (SF-36) at week 12 compared with baseline (visit 1) and control group

    The score of SF-36 ranges from 0 to 100, and 100 represents the best

    Measured: Up to 12 weeks after treatment initiation

  7. The incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) events at week 14 compared with baseline (visit 1) and control group.

    Measured: Up to 14 weeks after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07080632
Sponsor's protocol ID
CBSinICH
Status last verified
Sep 2025
First submitted
10 Jul 2025
Last updated
1 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang F, Deng Y, Wang H, Fu J, Wu G, Duan Z, Zhang X, Cai Y, Zhou H, Yin J, He Y. Gut microbiota-mediated ursodeoxycholic acids regulate the inflammation of microglia through TGR5 signaling after MCAO. Brain Behav Immun. 2024 Jan;115:667-679. doi: 10.1016/j.bbi.2023.11.021. Epub 2023 Nov 19.

    PubMed 37989444

  • Martinez-Vacas A, Di Pierdomenico J, Gallego-Ortega A, Valiente-Soriano FJ, Vidal-Sanz M, Picaud S, Villegas-Perez MP, Garcia-Ayuso D. Systemic taurine treatment affords functional and morphological neuroprotection of photoreceptors and restores retinal pigment epithelium function in RCS rats. Redox Biol. 2022 Nov;57:102506. doi: 10.1016/j.redox.2022.102506. Epub 2022 Oct 14.

    PubMed 36270186

  • Ohsawa Y, Hagiwara H, Nishimatsu SI, Hirakawa A, Kamimura N, Ohtsubo H, Fukai Y, Murakami T, Koga Y, Goto YI, Ohta S, Sunada Y; KN01 Study Group. Taurine supplementation for prevention of stroke-like episodes in MELAS: a multicentre, open-label, 52-week phase III trial. J Neurol Neurosurg Psychiatry. 2019 May;90(5):529-536. doi: 10.1136/jnnp-2018-317964. Epub 2018 Apr 17.

    PubMed 29666206

  • Liu K, Zhu R, Jiang H, Li B, Geng Q, Li Y, Qi J. Taurine inhibits KDM3a production and microglia activation in lipopolysaccharide-treated mice and BV-2 cells. Mol Cell Neurosci. 2022 Sep;122:103759. doi: 10.1016/j.mcn.2022.103759. Epub 2022 Jul 25.

    PubMed 35901929

  • Jangra A, Gola P, Singh J, Gond P, Ghosh S, Rachamalla M, Dey A, Iqbal D, Kamal M, Sachdeva P, Jha SK, Ojha S, Kumar D, Jha NK, Chopra H, Tan SC. Emergence of taurine as a therapeutic agent for neurological disorders. Neural Regen Res. 2024 Jan;19(1):62-68. doi: 10.4103/1673-5374.374139.

    PubMed 37488845

  • Hurley MJ, Bates R, Macnaughtan J, Schapira AHV. Bile acids and neurological disease. Pharmacol Ther. 2022 Dec;240:108311. doi: 10.1016/j.pharmthera.2022.108311. Epub 2022 Nov 16.

    PubMed 36400238

  • Khalaf K, Tornese P, Cocco A, Albanese A. Tauroursodeoxycholic acid: a potential therapeutic tool in neurodegenerative diseases. Transl Neurodegener. 2022 Jun 4;11(1):33. doi: 10.1186/s40035-022-00307-z.

    PubMed 35659112

  • Li CX, Wang XQ, Cheng FF, Yan X, Luo J, Wang QG. Hyodeoxycholic acid protects the neurovascular unit against oxygen-glucose deprivation and reoxygenation-induced injury in vitro. Neural Regen Res. 2019 Nov;14(11):1941-1949. doi: 10.4103/1673-5374.259617.

    PubMed 31290452

  • Bhargava P, Smith MD, Mische L, Harrington E, Fitzgerald KC, Martin K, Kim S, Reyes AA, Gonzalez-Cardona J, Volsko C, Tripathi A, Singh S, Varanasi K, Lord HN, Meyers K, Taylor M, Gharagozloo M, Sotirchos ES, Nourbakhsh B, Dutta R, Mowry EM, Waubant E, Calabresi PA. Bile acid metabolism is altered in multiple sclerosis and supplementation ameliorates neuroinflammation. J Clin Invest. 2020 Jul 1;130(7):3467-3482. doi: 10.1172/JCI129401.

    PubMed 32182223

  • Liu HW, Gong LN, Lai K, Yu XF, Liu ZQ, Li MX, Yin XL, Liang M, Shi HS, Jiang LH, Yang W, Shi HB, Wang LY, Yin SK. Bilirubin gates the TRPM2 channel as a direct agonist to exacerbate ischemic brain damage. Neuron. 2023 May 17;111(10):1609-1625.e6. doi: 10.1016/j.neuron.2023.02.022. Epub 2023 Mar 14.

    PubMed 36921602

  • Matsui M, Nakanishi T, Noguchi T, Ferrone S. Synergistic in vitro and in vivo anti-tumor effect of daunomycin-anti-96-kDa melanoma-associated antigen monoclonal antibody CL 207 conjugate and recombinant IFN-gamma. J Immunol. 1988 Aug 15;141(4):1410-7.

    PubMed 3135332

  • Thakkar M, Edelenbos J, Dore S. Bilirubin and Ischemic Stroke: Rendering the Current Paradigm to Better Understand the Protective Effects of Bilirubin. Mol Neurobiol. 2019 Aug;56(8):5483-5496. doi: 10.1007/s12035-018-1440-y. Epub 2019 Jan 5.

    PubMed 30612336

  • Vitek L, Tiribelli C. Bilirubin: The yellow hormone? J Hepatol. 2021 Dec;75(6):1485-1490. doi: 10.1016/j.jhep.2021.06.010. Epub 2021 Jun 18.

    PubMed 34153399

  • Zhong XM, Ren XC, Lou YL, Chen MJ, Li GZ, Gong XY, Huang Z. Effects of in-vitro cultured calculus bovis on learning and memory impairments of hyperlipemia vascular dementia rats. J Ethnopharmacol. 2016 Nov 4;192:390-397. doi: 10.1016/j.jep.2016.09.014. Epub 2016 Sep 9.

    PubMed 27616028

  • Lu F, Wang L, Chen Y, Zhong X, Huang Z. In vitro cultured calculus bovis attenuates cerebral ischaemia-reperfusion injury by inhibiting neuronal apoptosis and protecting mitochondrial function in rats. J Ethnopharmacol. 2020 Dec 5;263:113168. doi: 10.1016/j.jep.2020.113168. Epub 2020 Jul 27.

    PubMed 32730869

Questions about this trial

What is this clinical trial studying?

A study testing Calculus bovis sativus (CBS) and Natural Calculus Bovis(NCB) in people with Intracerebral Hemorrhage and Brain Hemorrhage, run by Tongji Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 59 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qiang Zhang, MD (+8615827166616, zhangqiang_glia@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Modified Rankin Scale (mRS) (time frame: Up to 12 weeks after treatment initiation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07080632, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.

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