Testing galantamine, a plant-derived drug, for acute ischemic stroke
Tests galantamine alongside standard care in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07003386, who can take part
Where in China
- Shanghai Yueyang Integrated Medicine HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Yueyang Integrated Medicine Hospital
- Trial code
- NCT07003386
- Record updated
- 16 September 2025
- Original description
Although mechanical thrombectomy or thrombolytic therapy for large vessels can achieve a revascularization rate (TICI ≥2b) of over 90%, 30-50% of patients still exhibit poor functional outcomes. This phenomenon of "ineffective reperfusion" suggests that microcirculatory dysfunction plays a decisive role in post-stroke neural injury. Therefore, it is necessary to combine brain protection strategies with microcirculatory reperfusion therapy to improve the functional prognosis of stroke patients.Increasing cerebral blood flow (CBF) and neurovascular unit (NVU)-based cerebral protection are current hotspots in the emergency treatment of stroke.Read full original descriptionShow less
Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke Based on the Neurovascular Unit
Although mechanical thrombectomy or thrombolytic therapy for large vessels can achieve a revascularization rate (TICI ≥2b) of over 90%, 30-50% of patients still exhibit poor functional outcomes. This phenomenon of "ineffective reperfusion" suggests that microcirculatory dysfunction plays a decisive role in post-stroke neural injury. Therefore, it is necessary to combine brain protection strategies with microcirculatory reperfusion therapy to improve the functional prognosis of stroke patients.Increasing cerebral blood flow (CBF) and neurovascular unit (NVU)-based cerebral protection are current hotspots in the emergency treatment of stroke.
Galantamine, extracted from Lycoris aurea (a traditional Chinese medicinal herb), is an acetylcholinesterase inhibitor (AChEI) that has been widely recognized for improving cerebral blood flow and modulating inflammatory responses in ischemic stroke (IS).
Therefore, the applicant will conduct an internationally compliant, randomized controlled clinical study with routine treatment to evaluate the efficacy of galantamine in the treatment of acute cerebral infarction. This project will conduct a comprehensive assessment of the drug's efficacy from multiple aspects, including improvements in stroke-related outcomes, Traditional Chinese Medicine (TCM) syndrome manifestations, cognitive function, cerebral blood flow, and inflammatory factors.
Inclusion: Aged > 18 years and < 85 years, regardless of gender; Meeting the diagnostic criteria for ischemic stroke in Western medicine; Meeting the diagnostic criteria for stroke (Zhongfeng) in Traditional Chinese Medicine (TCM); Diagnosis of acute ischemic stroke within 72h of symptom onset; A score of 4-25 points on the National Institute of Health Stroke Scale (NIHSS); First onset of the disease, or no severe sequelae related to previous onset; The patient and their legal guardian voluntarily sign the informed consent form for the study.
Exclusion: Patients who are currently using other cholinesterase inhibitor drugs or have used other cholinesterase inhibitor drugs within the past 3 months; Confirmed by cranial imaging examination to have diseases causing similar symptoms such as brain tumors, encephalitis, and brain abscesses; or confirmed to have hemorrhagic cerebral infarction,epidural hematoma,intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc; Elderly patients with physical weakness or patients complicated with infection; Patients with a history of mental illness or dementia; Patients with other severe organ or systemic diseases, accompanied by malignant tumors in any organ or system, or undergoing anti-tumor treatment, with an expected survival time of < 6 months; A significant history of drug or alcohol abuse; Patients with epilepsy, hyperkinesis, mechanical intestinal obstruction, bronchial asthma, angina pectoris, bradycardia, or glaucoma; Patients with contraindications to brain magnetic resonance imaging (MRI) examination, such as patients with implanted cardiac pacemakers, patients with implanted artificial joints or orthopedic plates, patients with claustrophobia, etc; Patients with severe abnormalities of liver and kidney function (liver function: alanine aminotransferase [ALT] >2 times the upper limit of normal [ULN]; renal function: creatinine [Cr]>1.5 times the upper limit of normal [ULN]); Women who test positive for blood human chorionic gonadotropin (HCG) (i.e., HCG ≥ 5 mIU/mL) during pregnancy screening, plan to become pregnant during the trial, or are breastfeeding; Patients who are currently participating in other clinical trials or have participated in other clinical trials within the past 1 month.