Efficacy and Safety of Calculus Bovis Sativus (CBS) for Idiopathic Inflammatory Demyelinating Disease (CBSinIIDD)
NCT Number: NCT06474520
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Idiopathic Inflammatory Demyelinating Disease|Multiple Sclerosis|Neuromyelitis Optica Spectrum Disorder|Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease|Acute Disseminated Encephalomyelitis
Interventions: DRUG: Calculus bovis sativus (CBS)
Sponsor: Tongji Hospital
Collaborators: Wuhan Jianmin DAPENG Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 250
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:
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.

Primary Outcome Measures: The Modified Rankin Scale (mRS), To assess mRS of subjects within 12 weeks after treatment initiation. The score ranges from 0 to 5. 5 represents the worst., Up to 12 weeks after treatment initiation|Expanded Disability Status Scale (EDSS), To assess EDSS of subjects within 12 weeks after treatment initiation. The score ranges from 0 to 10. 10 represents the worst., Up to 12 weeks after treatment initiation|Incidence and Severity of Adverse Effects (AEs) and Severe Adverse Effects (SAEs), To evaluate the 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 inflammatory lesions 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 newly increased inflammatory lesions on gadolinium-enhanced T1 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|Quantitative and qualitative changes in Montreal cognitive assessment scale (MoCA) at week 12 compared with baseline (visit 1) and control group., 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 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|Quantitative and qualitative changes in 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