RecruitingNot ApplicableNCT06474520

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


Sponsor

Tongji Hospital

Enrollment

250 participants

Start Date

Aug 8, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called CBS (Calculus Bovis Sativus) in people with inflammatory demyelinating diseases — conditions where the immune system damages the protective coating around nerves, causing problems with movement, vision, and coordination. These conditions include multiple sclerosis (MS), neuromyelitis optica (NMO), and related diseases. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with MS, AQP4-positive NMO, MOGAD, or a related nerve-demyelinating condition - Your disability score is relatively low (EDSS ≤ 4) - Your neurological condition has been stable for the past 30 days - OR you are a healthy adult (for a control group comparison) **You may NOT be eligible if...** - You have a serious heart, liver, kidney, or other organ condition - You have had cancer recently (unless in remission for over 5 years) - You have had a GI surgery or have inflammatory bowel disease - You have HIV, active Hepatitis B or C, or active tuberculosis - You are pregnant or breastfeeding - You have recently had a live vaccine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCalculus bovis sativus (CBS)

Subjects will orally receive 100mg CBS per day from day 1 to day 84.


Locations(1)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT06474520


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