NCT07163702尚未招募2 期
Efficacy and Safety of Xinglou Chengqi Granule for Acute Ischemic Stroke (EXACT): a Multi-center, Randomized, Double-blinded, Dose-exploration Ⅱa Trial
Dongzhimen Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change of NIHSS score from baseline to day 14.
研究概览
简要总结
This is a Ⅱa clinical trial. The purpose of this study is to preliminarily explore the optimal dosage of Xinglou Chengqi Granules in the treatment of acute ischemic stroke and to evaluate the efficacy and safety of Xinglou Chengqi Granules for acute ischemic stroke.
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 70 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.
- •Meet the criteria of TCM phlegm-heat and fu-organ excess syndrome.
- •Acute ischemic stroke within 7 days after onset.
- •6 ≤ NIHSS <
- •Aged 18-70 years, male or female.
- •The patient or representative has signed informed consent.
排除标准
- •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 )
- •Received or planned thrombolysis or endovascular therapy after onset.
- •Known severe liver or kidney dysfunction (alanine aminotransferase or aspartate transaminase > 2.5 times the upper limit of normal value, serum creatinine > 1.5 times the upper limit of normal value)
- •With cancers or uncontrolled diabetes.
- •The expected survival time is less than 3 months.
- •Patients who have used other traditional Chinese medicine for treating acute ischemic stroke since stroke onset.
- •Patients with severe mental disorders, dementia, or other comorbid diseases that may affect neurological function examination.
- •With a history of alcohol or drug abuse or drug dependence.
- •Those known to be allergic to the investigated drug or its components.
- •Pregnancy, potential pregnancy, or breastfeeding.
- •Currently participating in other clinical trials during the past 3 months.
- •Those who are judged by researchers to have poor compliance or are not suitable for participating in this study for any other reason.
研究组 & 干预措施
High-dose group
Experimental
16 g of Xinglou Chengqi granules will be given to participants in the high-dose group.
干预措施: High-dose Xinglou Chengqi granules (Drug)
Low-dose group
Active Comparator
8 g of Xinglou Chengqi granules and 8 g of placebo will be given to participants in the low-dose group.
干预措施: Low-dose Xinglou Chengqi granules and placebo (Drug)
结局指标
主要结局
The change of NIHSS score from baseline to day 14.
时间窗: Baseline and Day 14.
The change of the National Institutes of Health stroke scale (NIHSS) score from baseline to day 14 will be analyzed between groups.
次要结局
- The proportions of patients with mRS ≤ 2 or mRS ≤ 1.(Day 30, Day 60 and Day 90.)
- The change of NIHSS score(Day 7, day 30, day 60, day 90.)
- The proportion of patients with Barthel Index score ≥ 95 or ≥ 75.(day 7, day 14, day 30, day 60, day 90.)
- The change of EQ-5D score.(day 7, day 14, day 30, day 60, day 90.)
- The incidence of new cardiovascular events.(day 7, day 14, day 30, day 60, day 90.)
研究者
Ying Gao
Professor
Dongzhimen Hospital, Beijing
研究点 (1)
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