Ignite Creation Date:
2024-07-17 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474507
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-02
Brief Title:
Efficacy and Safety of Calculus Bovis Sativus CBS for Ischemic Cerebral Vascular Disease CBSinICVD
Sponsor:
Tongji Hospital
Organization:
Tongji Hospital
Study Overview
Official Title:
An Open Label Clinical Trial to Evaluate the Efficacy and Safety of Calculus Bovis Sativus CBS for Ischemic Cerebral Vascular Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The most common cause of death for Chinese patients is ischemic cerebrovascular diseasesICVD 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None