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临床试验/KCT0003997
KCT0003997尚未招募未知

Clinical Trial to Assess the Effectiveness and to Safety of UC in the Patients with Ischemic Stroke: a multi-center randomized controlled pilot trial)

Kyung Hee University0 个研究点目标入组 60 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional Study

入排标准

年龄范围
19(Year) 至 80(Year)(—)
性别
All

入选标准

  • (1) Men and women who are not pregnant nor breastfeeding, aged 19 to 80 years
  • (2) Patients diagnosed with acute ischemic stroke in brain image(MR or CT)
  • (3) Patients participating within 90 days of the onset
  • (4) Patients with upper or lower limb weakness (Fugl-Meyer Assessment (FMA) motor score = 55 and 1= Medical Research Council Scale score (at least one arm or leg motor power grade) =4)
  • (5) Patients with mild to moderate ischemic stroke (4= Korean version of the National Institute of Health Stroke Scale (K-NIHSS) score =15)
  • (6) modified Rankin Scale (mRS) score before the recent ischemic stroke =1
  • (7) Subject who have no communication problems and voluntary agree to participate

排除标准

  • (1) Patients with motor weakness caused by previous stroke
  • (2) Patients diagnosed with degenerative brain disease(e.g., Parkinson's disease, Alzheimer's disease)
  • (3) Patients diagnosed with hemorrhagic stroke(intracranial hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage) in brain image(MR or CT)
  • (4) Taking amphetamine, Selective Serotonin Reuptake Inhibitors(SSRI), or antipsychotic medication
  • (5) Patients with other brain disease (e.g., brain tumor, traumatic brain injury, arteriovenous malformation, moyamoya disease, and ischemic stroke caused by these disease, etc.)
  • (6) Previous history of brain surgery
  • (7) Patients who already have motor weakness due to other disease
  • (8) Unstable vital signs at screening (e.g., systolic blood pressure (sBP) =160mmHg, even though taking antihypertensive drugs)
  • (9) Serious disease(e.g., liver disease, kidney disease, severe heart failure( = New York Heart Association classification (NYHA) Class III), etc.)
  • (10) Taking drugs that can cause liver or renal dysfunction
  • (11) Patients who diagnosed or treated cancer within 6 months
  • (12) Taking other herbal medicines within 4 weeks before participating in the clinical trial
  • (13) Blood test meets the following criteria:
  • 1) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level = x2 of normal range
  • 2) Creatinine > 2.0mg/dL
  • 3) Hemoglobin < 10g/dL, Hct < 25%, Platelet < 100,000/mm3
  • (14) Participation in other clinical studies within 30 days
  • (15) Participants who are judged by investigator to be nonconformity for participation in the trial for other reasons

研究者

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