Clinical Evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy

Conditions
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Intracerebral Hemorrhage, Hypertensive, Traditional Chinese Medicine

Intervention / Treatment
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* Drug: AICH-PXZY
* Drug: AICH-without PXZY
* Drug: AICH-placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 GCS≥6 Sign the informed consent form Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: AICH-PXZY<br>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). | Drug: AICH-PXZY<br>* 8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days<br>* Other names: herbal medicine with Hirudo, Tabanus;Drug: AICH-without PXZY<br>* AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days<br>* Other names: herbal medicine without Hirudo, Tabanus;Drug: AICH-placebo<br>* The placebo is made up of Starch, bitter taste and cyclodextrin<br>* Other names: Placebo;|
| Experimental: Experimental: AICH-without PXZY<br>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). | Drug: AICH-PXZY<br>* 8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days<br>* Other names: herbal medicine with Hirudo, Tabanus;Drug: AICH-without PXZY<br>* AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days<br>* Other names: herbal medicine without Hirudo, Tabanus;Drug: AICH-placebo<br>* The placebo is made up of Starch, bitter taste and cyclodextrin<br>* Other names: Placebo;|
| Placebo Comparator: Placebo: AICH-placebo<br>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). | Drug: AICH-PXZY<br>* 8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days<br>* Other names: herbal medicine with Hirudo, Tabanus;Drug: AICH-without PXZY<br>* AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days<br>* Other names: herbal medicine without Hirudo, Tabanus;Drug: AICH-placebo<br>* The placebo is made up of Starch, bitter taste and cyclodextrin<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6-72h within onset, 24hrs, 10-14days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GCS scoring scale | The Glasgow score was used to assess the coma index. | 6-72hours within onset, 24hours later, 3 months | 
| National Institute of Health of stroke scale | The NIHSS is for evaluation of neurological deficits. | 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. | 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. | 3 months | 
| fatality rate | Any cause of death within the entire treatment 10ds and follow-up 90ds. | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood-breaking Decotion