Clinical Evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy
试验速览
- 阶段
- 4 期
- 入组人数
- 306
- 试验地点
- 2
- 主要终点
- Hematoma enlargement
研究概览
简要总结
The purpose of this research is to use the "Removing Blood Stasis Decotion" of traditional Chinese medicine treating the acute stage of cerebral hemorrhage with stroke associated pneumonia to explore the impact of "Removing Blood Stasis Therapy" on intestinal microbial flora either within the time window from 6 to 72 hours onset.
详细描述
objective
to investigate the impact and immunologic mechanism of using the "Removing Blood Stasis Decotion" treatment in SAP after Acute Cerebral Hemorrhage with the concept of Intestinal Micro Ecological Regulation.
Methods: from 2017.01 to 2022.12, 240 cases of AICH, 306 cases of hypertension will be included in 7 research centers. The AICH patients are randomly into 3 groups within 6 to 72hrs from onset, thus there are 3 groups and the treatment will last for 10 days: group A，Removing Blood Stasis herbal medicine(8 herbals); Group B, herbal medicine without Poxuezhuyu activating herbal(6 herbals); Group C, placebo medicine of Chinese medicine.All the patients will be treated according AHA guideline of AICH and will be set to the brain CT and chest X-ray at the onset, 24h later and 10-14days after treatment. The venous blood，feces Specimen and the sputum will be collected in the time point of 6 to 72hrs within onset , 24h later, and 10-14days after treatment.So the rate of enlargement of brain hematoma and the development of SAP in the 72h later, mortality rate in the two weeks and the disability rate in the 90 days can be evaluated.
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)
盲法说明
Our randomized program was completed by the key research laboratory of clinical research from the Traditional Chinese medicine Hospital of Guangdong Province. We design 306 cases into three groups: Group A, B, C in the proportion of 1:1:1. Group A is the experimental group used RBS, which include 8 herbals. Group B is the experimental group used PBS, which include all the herbals in Group A except Leech and Tabanus, rhubarb. Group C is a placebo group. This study adopts a stratified random sampling method and intra slice randomization on the basis of using PROC PLAN progress on SAS V9.2. On the other hand, this trial measures and the control measures will be made blind doubly. The surface of the opaque random envelopes will indicate the information of the test name, hospital name and the entry sequence number of patient. The research process of incorporating patient, dispensing medicine depending on the random envelopes and ect will all be supervised by the researchers each other.
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
- •Greater than or equal to 18 years old while younger than 80 years old
- •acute cerebral hemorrhage confirmed by brain CT scan within 6 to72 hours from onset
- •Sign the informed consent form
排除标准
- •Tests have confirmed that cerebral hemorrhage caused by brain tumor, blood diseases, cerebrovascular malformation (anomaly) or aneurysm, etc;
- •patients with Severe heart, liver and renal insufficiency.
- •Intolerance to traditional Chinese medicine (TCM), allergic constitution.
- •patients with severe cerebral hernia in the early onset
- •Compliance is poor.
研究组 & 干预措施
Experimental: AICH-PXZY
Removing Blood Stasis medicine with folium sennae , Polygonum cuspidatum and so on, 8 herbals, Tong-fu-xing-shen. The intervention in this group includes po AICH-PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
干预措施: AICH-PXZY (Drug)
Experimental: AICH-PXZY
Removing Blood Stasis medicine with folium sennae , Polygonum cuspidatum and so on, 8 herbals, Tong-fu-xing-shen. The intervention in this group includes po AICH-PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
干预措施: AICH-without PXZY (Drug)
Experimental: AICH-PXZY
Removing Blood Stasis medicine with folium sennae , Polygonum cuspidatum and so on, 8 herbals, Tong-fu-xing-shen. The intervention in this group includes po AICH-PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
干预措施: AICH-placebo (Drug)
Experimental: AICH-without PXZY
Removing Blood Stasis medicine without folium sennae and Snakegourd seed, 6 herbals, without the effect of Poxuezhuyu. The intervention in this group includes po AICH-without PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
干预措施: AICH-PXZY (Drug)
Experimental: AICH-without PXZY
Removing Blood Stasis medicine without folium sennae and Snakegourd seed, 6 herbals, without the effect of Poxuezhuyu. The intervention in this group includes po AICH-without PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
干预措施: AICH-without PXZY (Drug)
Experimental: AICH-without PXZY
Removing Blood Stasis medicine without folium sennae and Snakegourd seed, 6 herbals, without the effect of Poxuezhuyu. The intervention in this group includes po AICH-without PXZY bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
干预措施: AICH-placebo (Drug)
Placebo: AICH-placebo
The placebo is made up of Starch, bitter taste and cyclodextrin. The intervention in this group includes po AICH-placebo bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
干预措施: AICH-PXZY (Drug)
Placebo: AICH-placebo
The placebo is made up of Starch, bitter taste and cyclodextrin. The intervention in this group includes po AICH-placebo bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
干预措施: AICH-without PXZY (Drug)
Placebo: AICH-placebo
The placebo is made up of Starch, bitter taste and cyclodextrin. The intervention in this group includes po AICH-placebo bid and the routine treatment of Western Medicine.Torn the medicine bag and take it after mixing with 50-80ml warm water（Or take by nasal feeding).
干预措施: AICH-placebo (Drug)
结局指标
主要结局
Hematoma enlargement
时间窗: 6-72h within onset, 24hrs, 10-14days
The hematoma volume enlarged 33% or increased 12.5ml defined as hematoma enlargement which are compared with the two CT scans(6-72h within onset and 24h after onset,or 6-72h within onset and 10-14days)
次要结局
- GCS scoring scale(6-72hours within onset, 24hours later, 3 months)
- National Institute of Health of stroke scale(6-72hours within onset, 24hours later, 3 months)
- modified rankin scale(3 months)
- BI index(3 months)
- Social function activity questionnaire(FAQ)(3 months)
- fatality rate(3 months)