Trials / Recruiting
RecruitingNCT06474520
Efficacy and Safety of Calculus Bovis Sativus (CBS) for Idiopathic Inflammatory Demyelinating Disease (CBSinIIDD)
An Open Label Clinical Trial to Evaluate the Efficacy and Safety of Calculus Bovis Sativus (CBS) for Idiopathic Inflammatory Demyelinating Disease
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- Tongji Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Idiopathic Inflammatory Demyelinating Disease
- Multiple Sclerosis
- Neuromyelitis Optica Spectrum Disorder
- Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
- Acute Disseminated Encephalomyelitis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Calculus bovis sativus (CBS) | Subjects will orally receive 100mg CBS per day from day 1 to day 84. |
Timeline
- Start date
- 2024-08-08
- Primary completion
- 2029-07-01
- Completion
- 2029-12-01
- First posted
- 2024-06-25
- Last updated
- 2024-09-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06474520. Inclusion in this directory is not an endorsement.