Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 85Years
All Genders
NCT07003386

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

Led by Shanghai Yueyang Integrated Medicine Hospital · Updated on 2025-09-16

66

Participants Needed

1

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

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 (Zhongfeng) according to Traditional Chinese Medicine criteria
  • Acute ischemic stroke diagnosed within 72 hours of symptom onset
  • National Institute of Health Stroke Scale (NIHSS) score between 4 and 25 points
  • First stroke or no severe after-effects from a previous stroke
  • Patient and legal guardian voluntarily sign informed consent
Not Eligible

You will not qualify if you...

  • Brain tumors, encephalitis, brain abscess, hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage confirmed by imaging
  • Severe liver or kidney dysfunction (ALT over 2 times upper limit of normal; creatinine over 1.5 times upper limit of normal)
  • Elderly patients with physical weakness or infection
  • History of mental illness or dementia
  • Severe organ or systemic diseases or malignant tumors with expected survival under 6 months
  • History of drug or alcohol abuse
  • Women who are pregnant, planning pregnancy, breastfeeding, or positive for blood human chorionic gonadotropin (HCG)
  • Participation in other clinical trials within the past month
  • Current or recent use of cholinesterase inhibitor drugs within 3 months
  • Epilepsy, hyperkinesis, mechanical intestinal obstruction, bronchial asthma, angina pectoris, bradycardia, or glaucoma
  • Contraindications to brain MRI such as implanted pacemakers, artificial joints, orthopedic plates, or claustrophobia

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, China, 200080

Actively Recruiting

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Research Team

C

Chunxiang Chen

CONTACT

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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