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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
306
8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
The placebo is made up of Starch, bitter taste and cyclodextrin
Guangdong Provincial Science and Technology Agency
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
Hematoma enlargement
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)
Time frame: 6-72h within onset, 24hrs, 10-14days
GCS scoring scale
The Glasgow score was used to assess the coma index.
Time frame: 6-72hours within onset, 24hours later, 3 months
National Institute of Health of stroke scale
The NIHSS is for evaluation of neurological deficits.
Time frame: 6-72hours within onset, 24hours later, 3 months
BI index
BI index \<90 defines life cannot be independent. The percentage of BI 100-90 points in the three groups was statistically followed up by 90ds.
Time frame: 3 months
Social function activity questionnaire(FAQ)
FAQ is mainly to know the quality of life and living habits of the patients and their families.
Time frame: 3 months
fatality rate
Any cause of death within the entire treatment 10ds and follow-up 90ds.
Time frame: 3 months
modified rankin scale
Scoring 2-5 is defined as disability, which can be divided into 4 grades: mild, moderate, severe and severe. The percentage of mRS 0-1 points in the three groups will be statistically followed up by 90ds.
Time frame: 3 months
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