Efficacy and Safety of Qingre Huatan Formula for the Prevention of Early Neurological Deterioration in Patients With Acute Ischemic Stroke : A Randomized Double-blind Placebo-controlled Pilot Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The incidence of early neurological deterioration within 7 days of onset
研究概览
简要总结
The purpose of this study is to assess the effectiveness and safety of Qingre Huatan formula versus placebo on preventing early neurological deterioration in patients with acute ischemic stroke within 48 hours after onset.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients diagnosed with acute ischemic stroke. Inpatients diagnosed of acute ischemic stroke.
- •Meet the criteria of TCM phlegm-heat syndrome
- •Patients at high-risk of END : Magnetic resonance imaging (MRI) reveals new ischemic lesions, with DWI-ASPECTS score ≤ 7, or presence of at least two risk factors of END.
- •Acute ischemic stroke within 48 hours after onset.
- •Aged 18-80 years, male or female.
- •The patient or representative has signed informed consent.
排除标准
- •Received or planned thrombolysis or endovascular therapy after onset.
- •Suspected secondary stroke caused by brain tumor, brain trauma, hemopathy, etc.
- •Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 )
- •Diseases that cause motor dysfunction, including osteoarthritis, etc.
- •Known severe liver or kidney dysfunction (alanine aminotransferase or aspartate transaminase > 2 times the upper limit of normal value, serum creatinine > 1.5 times the upper limit of normal value)
- •Known severe aphasia or mental illness affecting clinical information collection and evaluation.
- •Pregnancy, potential pregnancy or breastfeeding.
- •Currently participating in other clinical trials.
研究组 & 干预措施
Qingre Huatan Formula
Patients will receive orally administered Qingre Huatan Formula, combined with guidelines-based standard care.
干预措施: Qingre Huatan Formula (Drug)
Qingre Huatan Formula
Patients will receive orally administered Qingre Huatan Formula, combined with guidelines-based standard care.
干预措施: Guidelines-based standard care (Other)
Qingre Huatan Formula placebo
Patients will receive orally administered Qingre Huatan Formula placebo, combined with guidelines-based standard care.
干预措施: Qingre Huatan Formula placebo (Drug)
Qingre Huatan Formula placebo
Patients will receive orally administered Qingre Huatan Formula placebo, combined with guidelines-based standard care.
干预措施: Guidelines-based standard care (Other)
结局指标
主要结局
The incidence of early neurological deterioration within 7 days of onset
时间窗: Basline and Day 7
An increase of NIHSS ≥2 within 7 days of onset is considered as early neurological deterioration. The NIHSS (National Institute of Health Stroke Scale) is a neurological assessment tool for stroke patients, with scores ranging from 0 to 42.
次要结局
- Change in National Institute of Health Stroke Scale scores from baseline to 10 days (after the treatment)(Basline and 10 days after treatment initiation)
- The proportion of patients with modified Rankin Scale score ≤2 on day 30(Day 30)
- The proportion of patients with modified Rankin Scale score ≤2 on day 90(Day 90)
- Activity of daily living of patients measured by Barthel Index score on day 30(Day 30)
- Activity of daily living of patients measured by Barthel Index score on day 90(Day 90)
- Incidence of treatment-related adverse events(90 days after treatment initiation)
研究者
Ying Gao
Professor
Dongzhimen Hospital, Beijing