Actively Recruiting
Efficacy and Safety of Calculus Bovis Sativus (CBS) for Idiopathic Inflammatory Demyelinating Disease (CBSinIIDD)
Led by Tongji Hospital · Updated on 2024-09-20
250
Participants Needed
1
Research Sites
277 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
J
Jianmin Pharmaceutical Group Co., LTD.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of Calculus Bovis Sativus (CBS) for Idiopathic Inflammatory Demyelinating Disease (CBSinIIDD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 65 years who understand the study and provide informed consent
- Use of contraceptive measures during the study and for at least 30 days after the last dose for women of childbearing age and men
- Diagnosed with multiple sclerosis meeting the 2017 revised McDonald criteria
- Diagnosed with aquaporin protein-4-positive neuromyelitis optica spectrum disorder meeting 2015 consensus criteria
- Diagnosed with myelin oligodendrocyte glycoprotein antibody-related disease according to 2023 criteria
- Diagnosed with acute disseminated encephalomyelitis according to 2013 IPMSSG criteria with encephalopathy manifestations
- Expanded Disability Status Scale (EDSS) score of 4 or less at baseline
- Stable neurological examination within 30 days prior to baseline
- Healthy adults aged 18 years or older without underlying diseases (for healthy cohort)
You will not qualify if you...
- Clinically significant cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, urologic, pulmonary, neurological, dermatologic, psychiatric, or renal disease
- Untreated teratoma or thymoma at baseline
- Other causes of symptoms such as CNS infection, metabolic encephalopathy, epileptic disorders, mitochondrial disease, or Creutzfeldt-Jakob disease
- Herpes simplex encephalitis within the previous 24 weeks
- Surgery within 4 weeks prior to baseline except minor outpatient procedures
- Planned surgery during the study except minor surgery
- History of severe allergic or anaphylactic reactions to study treatment components
- Current or history of malignant disease except certain cured skin cancers
- Gastrointestinal surgery history except appendectomy or cholecystectomy over 6 months prior
- Active or recurrent gastrointestinal symptoms within 90 days prior to screening
- History of diverticulitis or severe gastrointestinal abnormalities
- Blood, plasma, or platelet donation within specified recent periods
- Active suicidal ideation or recent suicide attempt
- Significant abnormal laboratory or clinical findings preventing safe participation
- Pregnant or lactating, or planning pregnancy during study or within 3 months after last dose
- Mental or physical conditions hindering evaluation
- Uncontrolled blood pressure or significant heart conduction abnormalities
- Planned elective procedures after consent
- Conditions affecting absorption of study treatment
- History of hypersensitivity to heparin or heparin-induced thrombocytopenia
- History or positive test for HIV
- Current hepatitis B or active hepatitis C infection
- Recent severe or chronic infections
- Positive tuberculosis history or test
- Recent infections or recent use of live vaccines
- Contraindications to certain salvage therapies
- History of certain immunosuppressive treatments or stem cell transplantation
- Abnormal blood or urine test values at screening
- Previous participation in this study
- History of alcohol or drug abuse within the past year
- Participation in other clinical trials within 90 days
- Significant suicidal thoughts or behaviors within past 12 months
- Hearing, vision, language, or claustrophobia issues preventing assessments
- Other reasons deemed unsuitable by investigator or sponsor
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
K
Ke Shang, MD
CONTACT
K
Ke Shang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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