An Open Label Clinical Trial to Evaluate the Efficacy and Safety of Calculus Bovis Sativus (CBS) for Ischemic Cerebral Vascular Disease

What this Trial Is About

Ischemic cerebrovascular diseases (ICVD), especially cerebral infarction, are a leading cause of death and disability among Chinese patients, posing significant challenges to individuals, families, and society. Cerebral small vessel disease (CSVD), a form of ICVD, often begins subtly and is hard to detect until it causes vascular cognitive dysfunction. The disease process involves brain nerve cell damage due to ischemia and inflammation. Researchers seek to evaluate the effects of Calculus Bovis Sativus (CBS), a traditional medicine approved for treating comatose patients and known for its anti-inflammatory and neuroprotective properties, on ischemic cerebrovascular diseases in humans. This clinical trial includes three groups: patients with ICVD receiving general therapy plus CBS, patients with ICVD receiving only general therapy, and healthy adults receiving only CBS. CBS will be given orally at a dose of 100 mg daily for 84 days. The study is open-label and non-randomized, aiming to assess the safety and efficacy of CBS alongside standard treatments or alone in healthy individuals. Participants will be monitored up to 14 weeks after starting treatment. Evaluations include neurological and cognitive assessments such as the Modified Rankin Scale, NIH Stroke Scale, Mini-Mental State Examination, and Montreal Cognitive Assessment. Brain imaging will track changes in cerebral infarctions, white matter abnormalities, and microbleeds. Safety will be assessed by tracking adverse events and suicide risk. The study also collects data on participants' mental health and quality of life throughout the period.

Efficacy and Safety of Calculus Bovis Sativus (CBS) for Ischemic Cerebral Vascular Disease (CBSinICVD)