Actively Recruiting
Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke Based on the Neurovascular Unit
Led by Shanghai Yueyang Integrated Medicine Hospital · Updated on 2025-09-16
66
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of galantamine, a drug extracted from Lycoris aurea, in treating acute ischemic stroke. Despite high revascularization rates with current treatments like mechanical thrombectomy and thrombolytic therapy, many patients still face poor recovery due to microcirculatory dysfunction. This trial aims to assess how galantamine, known to improve cerebral blood flow and reduce inflammation, may enhance stroke-related outcomes, cognitive function, and Traditional Chinese Medicine syndrome symptoms. Participants will be randomly assigned to receive either standard treatment for acute ischemic stroke plus galantamine or standard treatment alone. Galantamine is given by intramuscular injection at a dose of 5.0 mg once daily, starting within 24 hours of hospital admission, and continuing for 10 days. The study follows participants for up to 90 days to monitor effects on neurological function, motor skills, cerebral blood flow, inflammatory markers, and quality of life. During the study, participants will undergo assessments including the National Institute of Health Stroke Scale (NIHSS), motor function tests, brain imaging, inflammatory factor measurements, and cognitive evaluations at multiple time points: baseline, 10 days, 30 days, and 90 days. Researchers will also evaluate functional independence and quality of life using established scales. The total participation duration extends to about three months, with ongoing safety monitoring and detailed analysis of treatment impact.
CONDITIONS
Brief Title
Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged over 18 years and under 85 years, any gender
- Diagnosed with ischemic stroke according to Western medicine criteria
- Diagnosed with stroke according to Traditional Chinese Medicine criteria
- Acute ischemic stroke diagnosed within 72 hours of symptom onset
- NIHSS score between 4 and 25 points
- First stroke occurrence or no severe sequelae from previous stroke
- Patient and legal guardian have voluntarily signed informed consent
You will not qualify if you...
- Brain diseases like tumors, encephalitis, brain abscess, or hemorrhagic stroke confirmed by imaging
- Severe liver dysfunction (ALT > 2 times upper limit) or kidney dysfunction (creatinine > 1.5 times upper limit)
- Elderly with physical weakness or infections
- History of mental illness or dementia
- Severe organ or systemic diseases including malignant tumors with expected survival under 6 months
- Significant history of drug or alcohol abuse
- Positive pregnancy test, planning pregnancy, or breastfeeding
- Participation in other clinical trials within the past month
- Use of cholinesterase inhibitors within the past 3 months
- Conditions like epilepsy, hyperkinesis, intestinal obstruction, asthma, angina, bradycardia, or glaucoma
- Contraindications to brain MRI such as implanted pacemakers, artificial joints, or claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 10 days
Participants receive galantamine via daily intramuscular injection for 10 days alongside standard treatment for acute ischemic stroke, or standard treatment alone.
Daily visits for 10 days
Duration - Up to 90 days after treatment
Participants are monitored for recovery and outcomes after treatment ends, including assessments up to 90 days after randomization.
Visits at Day 10, Day 30, and Day 90 post-randomization
Trial Site Locations
Total: 1 location
1
Shanghai Yueyang Integrated Medicine Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
Research Team
C
Chunxiang Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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