Actively Recruiting
Efficacy and Safety of Calculus Bovis Sativus (CBS) for Ischemic Cerebral Vascular Disease (CBSinICVD)
Led by Tongji Hospital · Updated on 2024-09-20
230
Participants Needed
2
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
The most common cause of death for Chinese patients is ischemic cerebrovascular diseases(ICVD), particularly cerebral infarction. It places a heavy burden on people, families, and society as a whole and poses considerable risks of death and disability. The disease known as CSVD has a subtle beginning, is difficult to identify, and is frequently detected only after it progresses to the point of vascular cognitive dysfunction. The primary ischemia necrosis of brain nerve cells and the activation of inflammatory cells are their pathologic processes. According to historical Chinese medical documents, bezoar possesses properties that can help prevent seizures, treat strokes, enhance cognitive function and mental well-being, and stimulate alertness. Calculus Bovis Sativus (CBS) is the most authentic formulation of bezoar ingredients compared to other bezoar products. It has received approval from the China Food and Drug Administration for the essential treatment of comatose patients. CBS consists of three primary constituents: bilirubin, bile acids, and taurine. Scientific evidence has demonstrated that all of these components possess anti-inflammatory, antioxidant, and neuroprotective properties. The investigators' objective is to carry out an investigator-initiated clinical study to assess the efficacy of orally administered CBS in treating ischemic cerebrovascular diseases in humans.
CONDITIONS
Official Title
Efficacy and Safety of Calculus Bovis Sativus (CBS) for Ischemic Cerebral Vascular Disease (CBSinICVD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and provide informed consent
- Age between 18 and 80 years old
- Women of childbearing age and men must use contraception during the study and for 30 days after last dose
- Diagnosed with ischemic stroke (NIHSS 1-24; mRS up to 3) or cerebral small vessel disease (Fazekas score 3; mRS up to 3 or 4 for recent small infarction)
- Stable neurological exam within 30 days before baseline
- Healthy adults aged 18 years without underlying diseases (for healthy cohort)
You will not qualify if you...
- Significant medical history or diseases affecting participation (heart, liver, kidney, immune, psychiatric, etc.)
- Untreated teratoma or thymoma at baseline
- Other neurological or metabolic disorders causing symptoms
- Herpes simplex encephalitis within past 24 weeks
- Recent surgery within 4 weeks except minor outpatient procedures
- Planned surgery during study except minor surgery
- Severe allergies or anaphylaxis history
- Current or past malignant disease except certain cured skin cancers
- History of significant gastrointestinal diseases or recent symptoms
- Recent blood, plasma, or platelet donation
- Active suicidal thoughts or recent suicide attempt
- Abnormal blood pressure outside 90-150 mmHg
- Certain heart conduction abnormalities or severe heart conditions
- Planned elective surgery during study
- Conditions affecting treatment absorption
- Hypersensitivity to heparin or history of heparin-induced thrombocytopenia
- HIV infection or positive test
- Active hepatitis B or C infection
- Recent or severe infections or symptoms
- Recent live vaccinations
- Contraindications to certain salvage therapies
- Prior treatments like stem cell transplantation or total lymphoid irradiation
- Abnormal lab values considered clinically significant
- Pregnant or lactating women or planning pregnancy during or shortly after study
- Mental or physical conditions hindering study assessments
- Hearing, vision, language, or psychological impairments affecting participation
- Participation in another clinical trial within past 90 days
- History of alcohol or drug abuse within past year
- Unwillingness or inability to comply with study requirements
- Other investigator-determined reasons making participation unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
2
Tongji Hospital of Tongji Medical College, 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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