Ignite Creation Date:
2024-07-17 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474520
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-03
Brief Title:
Efficacy and Safety of Calculus Bovis Sativus CBS for Idiopathic Inflammatory Demyelinating Disease CBSinIIDD
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 Idiopathic Inflammatory Demyelinating 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:
According to the records of traditional Chinese medicine CBS has the following functions clearing the heart resolving phlegm promoting bile secretion and calming the nerves It can treat fever coma delirium epilepsy convulsions in children dental caries throat swelling oral sores carbuncle and furuncle
The significant pathophysiological process of primary inflammatory demyelinating disease of the central nervous system hereinafter referred to as IIDD is the activation of the immune system of the central nervous system and the enhancement of inflammation It includes several common diseases multiple sclerosis MS neuromyelitis optica spectrum disorder NMOSD myelin oligodendrocyte glycoprotein antibody-related disease MOGAD acute disseminated encephalomyelitis ADEM concentric sclerosis tumor-like inflammatory demyelinating disease etc
Combined with the inspiration brought to us by the above background research especially bilirubin and bile acid are closely related to intestinal digestive function and CBS is clinically effective through oral administration by subjects the investigators speculate that CBS is likely to exert its immune anti-inflammatory and neuroprotective effects on the brain by changing the intestinal flora and regulating the brain-gut axis In terms of symptoms CBS is likely to have the effect of improving the clinical symptoms of IIDD subjects and reducing disability
The significant pathophysiological process of primary inflammatory demyelinating disease of the central nervous system hereinafter referred to as IIDD is the activation of the immune system of the central nervous system and the enhancement of inflammation It includes several common diseases multiple sclerosis MS neuromyelitis optica spectrum disorder NMOSD myelin oligodendrocyte glycoprotein antibody-related disease MOGAD acute disseminated encephalomyelitis ADEM concentric sclerosis tumor-like inflammatory demyelinating disease etc
Combined with the inspiration brought to us by the above background research especially bilirubin and bile acid are closely related to intestinal digestive function and CBS is clinically effective through oral administration by subjects the investigators speculate that CBS is likely to exert its immune anti-inflammatory and neuroprotective effects on the brain by changing the intestinal flora and regulating the brain-gut axis In terms of symptoms CBS is likely to have the effect of improving the clinical symptoms of IIDD subjects and reducing disability
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