Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShanghai Yueyang Integrated Medicine Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

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])

Elderly patients with physical weakness or patients complicated with infection

Patients with a history of mental illness or dementia

Trial design

Treatments tested in this trial

  • Galantamine
  • Standard treatment for acute ischemic stroke

Treatment groups

66 Participants
are divided into 2 treatment groups