Open Study of Calculus Bovis Sativus CBS Treatment for Idiopathic Inflammatory Demyelinating Diseases Including Multiple Sclerosis and Related Disorders

What this Trial Is About

Researchers are studying the use of Calculus Bovis Sativus CBS, a traditional Chinese medicine, for treating idiopathic inflammatory demyelinating diseases IIDD of the central nervous system. These diseases include multiple sclerosis, neuromyelitis optica spectrum disorder, myelin oligodendrocyte glycoprotein antibody-related disease, acute disseminated encephalomyelitis, and others. CBS is thought to influence immune and inflammatory responses through the brain-gut axis by altering intestinal flora, potentially improving symptoms and reducing disability in affected individuals. Participants in this open-label clinical trial will be divided into groups receiving different treatments some with IIDD will get general therapy plus CBS, while others with IIDD will receive only general therapy. A group of healthy participants will receive CBS alone. CBS is given orally at a dose of 100 mg daily for 84 days. The study aims to evaluate the efficacy and safety of CBS over this treatment period. During the study, participants will undergo various assessments including disability scales Modified Rankin Scale and Expanded Disability Status Scale, brain imaging to track inflammatory lesions, cognitive tests Mini-Mental State Examination, Montreal Cognitive Assessment, and mood scales Hamilton Anxiety and Depression Scales. Safety will be monitored by recording adverse effects up to 14 weeks after treatment begins. The study will also evaluate quality of life and suicide risk. Participants will be followed closely throughout the treatment and observation periods.

Efficacy and Safety of Calculus Bovis Sativus (CBS) for Idiopathic Inflammatory Demyelinating Disease (CBSinIIDD)