About this trial
The most common cause of death for Chinese patients is ischemic cerebrovascular diseases(ICVD), 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 known as CSVD has a subtle beginning, 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 ischemic cerebrovascular diseases in humans.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects are able to understand the purpose and risks of the study, provide informed consent, and authorize the use of confidential health information in accordance with national and local privacy regulations.
Both men and women are welcome, and the age at the time of providing informed consent is 18-80 years (inclusive).
All women of childbearing age and all men must use contraceptive measures during the study and for at least 30 days after the last dose of study treatment. In addition, subjects should not donate sperm or eggs during the study and for at least 30 days after the last dose of study treatment.
Must be diagnosed with
Disqualifiers
Medical History and Current Health Status 1.1. Any clinically significant cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, urologic, pulmonary, neurological, dermatologic, psychiatric, and renal disease or other major medical history that the investigator determines would preclude participation in the clinical trial.
Risk of infection 2.1. History of human immunodeficiency virus (HIV) or positive test results at screening.
Total lymphoid irradiation, cladribine, T-cell or T Cell recipient vaccination, total body irradiation, or total lymphoid irradiation at any time.
Stem cell transplantation at any time.
Trial design
Parallel
Treatments tested in this trial
Calculus bovis sativus (CBS)
DrugSubjects will orally receive 100mg CBS per day from day 1 to day 84.
Treatment groups
Trial outcomes
Primary outcomes
The Modified Rankin Scale (mRS)
To assess mRS of subjects within 12 weeks after treatment initiation
The National Institutes of Health Stroke Scale, NIHSS
To assess NIHSS of subjects within 12 weeks after treatment initiation
Incidence and Severity of AEs and SAEs
To evaluate the incidence of AEs and SAEs occurred within 14 weeks after treatment initiation
Secondary outcomes
The number of newly increased cerebral infarction on diffusion-weighted imaging at week 12 compared with baseline (visit 1) and control group.
The number of lacunes on T1 weighted imaging at week 12 compared with baseline (visit 1) and control group.
The number of white matter hyper-intensities on T2 flair weighted imaging at week 12 compared with baseline (visit 1) and control group.
The number of cerebral microbleeds on susceptibility weighted imaging at week 12 compared with baseline (visit 1) and control group.
Other outcomes
Fecal flora abundance at week 12 compared with baseline (visit 1).
Fecal metabolomics analysis at week 12 compared with baseline (visit 1).
Profiling of cell subtypes at week 12 compared with baseline (visit 1).
The value of SUVmax and ratio of T/B of inflammatory lesion in 18F-DPA-714 PET/MR imaging examinations at week 12 compared with baseline (visit 1)
Sponsors and contacts
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Tongji Hospital
Lead sponsor
Jianmin Pharmaceutical Group Co., LTD.
Collaborator