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.
Subjects are capable of understanding the purpose and risks of the study, providing informed consent and authorizing the use of confidential health information in accordance with national and local privacy regulations.
Both men and women are welcome, and the age at the time of providing informed consent is 18-65 years (inclusive).
All women of childbearing age and all men must use contraceptive measures during the study and for at least 30 days after the last dose of study treatment. In addition, subjects should not donate sperm or eggs during the study and for at least 30 days after the last dose of study treatment.
Must be diagnosed with
Any clinically significant cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, urologic, pulmonary, neurological, dermatologic, psychiatric, and renal disease or other major medical history that the investigator determines would preclude participation in the clinical trial.
Any untreated teratoma or thymoma at the baseline visit (randomization)
Other causes of symptoms, including central nervous system infection, septic encephalopathy, metabolic encephalopathy, epileptic disorders, mitochondrial disease, Klein-Levin syndrome, Creutzfeldt-Jakob disease, rheumatic disease, Reyes syndrome, or inborn errors of metabolism.
History of herpes simplex encephalitis within the previous 24 weeks. 1.5. Any surgical procedure within 4 weeks prior to baseline, except laparoscopic surgery or minor surgery (defined as surgery requiring only local anesthesia or conscious sedation, i.e., surgery that does not require general, neuraxial, or regional anesthesia and can be performed on an outpatient basis; e.g., toenail surgery, mole surgery, wisdom tooth extraction), excluding thymoma or teratoma removal.
Parallel
Calculus bovis sativus (CBS)
DrugSubjects will orally receive 100mg CBS per day from day 1 to day 84.
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.
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.
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
The number of newly increased inflammatory lesions on T2 flair weighted imaging at week 12 compared with baseline (visit 1) and control group.
The number of newly increased inflammatory lesions on gadolinium-enhanced T1 weighted imaging at week 12 compared with baseline (visit 1) and control group.
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.
Quantitative and qualitative changes in Montreal cognitive assessment scale (MoCA) at week 12 compared with baseline (visit 1) and control group.
Fecal flora abundance at week 12 compared with baseline (visit 1).
Quantitative and qualitative changes in fecal metabolomics analysis at week 12 compared with baseline (visit 1).
Profiling of cell subtypes at week 12 compared with baseline (visit 1).
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).
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Tongji Hospital
Lead sponsor
Jianmin Pharmaceutical Group Co., LTD.
Collaborator
