Efficacy and Safety of Calculus Bovis Sativus (CBS) for Ischemic Cerebral Vascular Disease (CBSinICVD)
NCT Number: NCT06474507
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ischemic Cerebrovascular Disease|Acute Ischemic Stroke|Cerebral Small Vessel Diseases
Interventions: DRUG: Calculus bovis sativus (CBS)
Sponsor: Tongji Hospital
Collaborators: Wuhan Jianmin DAPENG Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 230
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2029-12
Locations: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China

Summary:
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.

Primary Outcome Measures: The Modified Rankin Scale (mRS), To assess mRS of subjects within 12 weeks after treatment initiation, Up to 12 weeks after treatment initiation|The National Institutes of Health Stroke Scale, NIHSS, To assess NIHSS of subjects within 12 weeks after treatment initiation, Up to 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, Up to 14 weeks after treatment initiation
Secondary Outcome Measures: The number of newly increased cerebral infarction on diffusion-weighted imaging at week 12 compared with baseline (visit 1) and control group., Up to 12 weeks after treatment initiation|The number of lacunes on T1 weighted imaging at week 12 compared with baseline (visit 1) and control group., Up to 12 weeks after treatment initiation|The number of white matter hyper-intensities on T2 flair weighted imaging at week 12 compared with baseline (visit 1) and control group., Up to 12 weeks after treatment initiation|The number of cerebral microbleeds on susceptibility weighted imaging at week 12 compared with baseline (visit 1) and 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., The score of MMSE ranges from 0 to 30, and 30 represents the best., Up to 12 weeks after treatment initiation|The score of 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., Up to 12 weeks after treatment initiation|The score of subjective cognitive decline questionnaire (SCD) at week 12 compared with baseline (visit 1) and control group., The score of SCD ranges from 0 to 9, and 9 represents the worst., Up to 12 weeks after treatment initiation|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., Up to 12 weeks after treatment initiation|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., Up to 12 weeks after treatment initiation|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., Up to 12 weeks after treatment initiation|The incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) events at week 14 compared with baseline (visit 1) and control group, Up to 14 weeks after treatment initiation
Other Outcome Measures: Fecal flora abundance at week 12 compared with baseline (visit 1)., Up to 12 weeks after treatment initiation|Fecal metabolomics analysis at week 12 compared with baseline (visit 1)., Up to 12 weeks after treatment initiation|Profiling of cell subtypes at week 12 compared with baseline (visit 1)., Up to 12 weeks after treatment initiation|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), Up to 12 weeks after treatment initiation