NCT05277311Unknown不适用
Efficacy and Safety of LongShengZhi Capsule on Functional Recovery After Acute Ischaemic Stroke (LONGAN): A Randomized, Double-Blind, Placebo-Controlled Trial
Dongzhimen Hospital, Beijing0 个研究点目标入组 1,376 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,376
- 主要终点
- The proportion of patients with excellent outcome
研究概览
简要总结
The aim of the study is to determine if LongShengZhi Capsule is effective and safe in patients with ischemic stroke in comparison to placebo. This trial is a prospective, multicenter, randomized, placebo-controlled, double-blinded, parallel-group, superiority trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke patients within 7 days of onset
- •18 years of age or older, and gender not limited
- •NIHSS score of 4 to 15
排除标准
- •Secondary stroke caused by a tumor, traumatic brain injury, hematological disease, or other diseases with a confirmed diagnosis
- •Pre-stroke mRS score of more than 1
- •Known severe liver or kidney dysfunction
- •Known allergies for ingredients in the investigational product
- •Known bleeding diathesis or coagulation disorder
- •Known medical condition likely to limit survival to less than 3 months
- •Pregnant women (clinically evident) or breastfeeding women
- •Participation in any investigational study in the previous 3 months
- •Known dementia, uncontrolled psychiatric problems
- •Any condition that could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study. The judgment is left to the discretion of the investigator
研究组 & 干预措施
LongShengZhi capsule
Experimental
Experimental group
干预措施: LongShengZhi capsule (Drug)
LongShengZhi capsule placebo
Placebo Comparator
Placebo group
干预措施: LongShengZhi capsule placebo (Drug)
结局指标
主要结局
The proportion of patients with excellent outcome
时间窗: 90 days after randomization
Excellent outcome defined as a modified Rankin scale (mRS) score ≤ 1 (scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death).
次要结局
- Distribution of the modified Rankin scale (mRS) scores(90 days after randomization)
- The proportion of adverse events (AEs)(90 days after randomization)
- The proportion of patients with good outcome(90 days after randomization)
- Changes in Cognitive function(90 days after randomization)
- Changes in National Institutes of Health Stroke Scale (NIHSS) scores(90 days after randomization)
- The proportion of patients with poor quality of life(90 days after randomization)
- The proportion of patients with functional independence(90 days after randomization)
- Changes in Motor function(90 days after randomization)
研究者
Ying Gao
Professor
Dongzhimen Hospital, Beijing
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