Anti-atherosclerosis and cardio-protective effects of the Angong Niuhuang Pill on a high fat and vitamin D3 induced rodent model of atherosclerosis.
Wen-Juan Fu, Ting Lei, Zhen Yin...
https://pubmed.ncbi.nlm.nih.gov/27880884Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06474520
An Open Label Clinical Trial to Evaluate the Efficacy and Safety of Calculus Bovis Sativus (CBS) for Idiopathic Inflammatory Demyelinating Disease
Led by Tongji Hospital · Updated on 2024-09-20
250
Participants Needed
1
Research Sites
21 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
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.
CONDITIONS
Brief Title
Efficacy and Safety of Calculus Bovis Sativus (CBS) for Idiopathic Inflammatory Demyelinating Disease (CBSinIIDD)
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years who can understand the study purpose and provide informed consent
- Both men and women are eligible
- Women of childbearing age and men must use contraceptives during the study and for at least 30 days after last dose
- Diagnosed with multiple sclerosis meeting 2017 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 as per 2013 IPMSSG criteria with encephalopathy
- Expanded Disability Status Scale (EDSS) score of 4 or less at baseline
- Stable neurological exam within 30 days before 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 that precludes participation
- Untreated teratoma or thymoma at baseline
- Other causes of symptoms such as CNS infection or metabolic encephalopathy
- History of herpes simplex encephalitis within 24 weeks
- Recent surgery within 4 weeks except minor surgeries
- Planned surgery during study except minor surgery
- History of severe allergic reactions or allergies to study treatment components
- Current or past malignant disease except certain cured skin cancers
- Significant gastrointestinal diseases or symptoms
- Recent blood, plasma, or platelet donation
- Active suicidal thoughts or recent suicide attempt
- Abnormal vital signs or ECG abnormalities
- Planned elective procedures after consent
- Conditions affecting drug absorption
- History of hypersensitivity to heparin
- Positive HIV or active hepatitis B or C infections
- Recent severe or chronic infections
- History or positive test for tuberculosis
- Recent vaccination with live vaccines
- Contraindications to certain salvage therapies
- History of certain immune therapies or stem cell transplantation
- Abnormal laboratory tests considered clinically significant
- Pregnant or lactating women or planning pregnancy
- Participation in other clinical trials within 90 days
- Significant mental or physical conditions hindering study evaluation
- Hearing, vision, language, or claustrophobia issues preventing assessments
- Investigator judgment of unsuitability for inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive Calculus Bovis Sativus (CBS) orally at 100mg per day for up to 12 weeks. Participants in the control group receive general therapy without CBS. Healthy participants in the healthy cohort receive CBS at the same dosage.
Daily medication with periodic visits for assessments
Follow-up
Duration - Up to 2 weeks after treatment ends
Participants are monitored for safety, including incidence and severity of adverse effects after treatment completion.
1 to 2 visits for safety assessments
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
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Research Team
K
Ke Shang, MD
K
Ke Shang, MD
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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Jiawei Zhou, Tianlin Jiang, Jiahua Wang...
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Zhi-Jie Yu, Ying Xu, Wei Peng...
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Kayoko Shimada, Yuko Azuma, Masaya Kawase...
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Xinyue Li, Yaqi Yao, Meiling Chen...
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Yonggang Liu, Peng Tan, Shanshan Liu...
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Yu Tang, Zhu Han, Han Zhang...
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Kyoko Takahashi, Yuko Azuma, Kayoko Shimada...
https://pubmed.ncbi.nlm.nih.gov/20804621In vitro cultured calculus bovis attenuates cerebral ischaemia-reperfusion injury by inhibiting neuronal apoptosis and protecting mitochondrial function in rats.
Feibiao Lu, Lingfeng Wang, Yanyue Chen...
https://pubmed.ncbi.nlm.nih.gov/32730869