A Randomized, Controlled, Double-blind, Multi-center Clinical Study of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 464
- 试验地点
- 5
- 主要终点
- Disability rate
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke by the randomized, controlled, double-blind, multi-center trial design project.
详细描述
The main purpose of the study is to observe the clinical efficacy and safety of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke. This project is funded by Science and Technology Commission of Shanghai Municipality and will be carried out in 5 hospitals. Investigators will recruit 464 participants who meet the inclusion criteria and agree to participate in the research. Participants will be randomly assigned into experimental or placebo group. Granules of Shengdi Decoction is the therapeutic drug used in the experimental group. Each pack of the test drug contains 15 grams of rehmannia and 5 grams of rhubarb. While for the placebo group, each pack contains 2% rehmannia and rhubarb. Participants will receive a follow-up observation in the following 90 days. Modified Rankin Scale score (mRS), the mortality rate on day 7 and day 90 after treatment, National Institute of Health Stroke Scale (NIHSS), expansion rate of hematoma, the degree of edema and the expressions of inflammatory indicators will be detected to evaluate the clinical efficacy of Shengdi Dahuang Decoction.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of acute intracerebral hemorrhage；
- •CT scan reveals cerebral parenchymal hemorrhage and the volume of hematoma is <80ml;
- •The time from onset to confirmed diagnosis by CT scan is within 4 hours;
- •Enrolled and receive treatment within 12 hours from onset;
- •Age ≥18 years old;
- •Obtain approval from the patient or family members.
排除标准
- •The time from onset to confirmed diagnosis by CT scan is over 4 hours;
- •CT scan indicate that the sites of hemorrhage are in the cerebellum, brainstem and ventricle (note: in case of cerebral parenchymal hemorrhage combined with ventricular hemorrhage, patients will be excluded if the volume of ventricular hemorrhage is the larger one);
- •The volume of hematoma is above 80ml;
- •Glasgow Coma Scale (GCS) is ≤ 5 points;
- •The time from onset to confirmed diagnosis is over 12 hours;
- •Have a surgical treatment planning within 24 hours;
- •Cerebral hemorrhage caused by trauma, arteriovenous malformation, thrombolytic therapy, anticoagulant therapy or other reasons;
- •Patients with disabilities before onset (modified mRS score > 2);
- •Patients with severe primary diseases of the heart, lung, liver, kidney, endocrine systems or hematopoietic system;
- •Patients who have participated in other clinical trials within the past 1 month;
- •Pregnant or nursing women;
- •Allergic constitution (allergic to more than two kinds of food or medications).
研究组 & 干预措施
Shengdi Dahuang Decoction
To clarify the clinical effects of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke and to explore the possible mechanism. Participants will take the granules of Shengdi Dahuang Decoction that contains 15 grams of rehmannia and 5 grams of rhubarb, one pack per time, twice a day for 7 days.
干预措施: Granules of Shengdi Dahuang Decoction (Drug)
Placebo
To explore the effective clinical therapy in acute hemorrhagic stroke. Participants will take placebo contains 2% rehmannia and rhubarb, one pack per time, twice a day for 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Disability rate
时间窗: 90 days
Modified Rankin Scale score (mRS) will be graded on the 90th day after onset (mRS score ranges from 0 point (no symptoms at all) to 5 points (severe disability)).
Mortality rate on the 7th day
时间窗: 7 days
The proportion of deaths (mortality rate, %) in different groups on 7th day after treatment will be compared.
次要结局
- Mortality rate on the 90th day(90 days)
- Severity of neurological deficit(7 days)
- The proportion of hematoma enlargement cases(24 hours)
- Severity of edema(7 days)
研究者
Xiaofei Yu
Clinical Professor
ShuGuang Hospital