Clinical Re-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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In order to investigate the time window of acute intracerebral hemorrhage(AICH) by Blood Activating and Stasis Dispersing therapy and to verify traditional methods if it would influence or enlarge the brain hematoma, test is made by random double-blind controlled. Patients are classified to （0-6h）and (6-72h) teams. Herbs is separated too. The period of the therapy lasts two weeks, and the follow up should last three months. The main indexes are mortality rate, disability rate and the brain hematoma situation. The review is made by the reference to (NIHSS),(GCS) and so on. So, the window time is determined through this test.

Detailed Description
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objective: to investigate the safety and effect of acute cerebral hemorrhage treated with Blood Activating and Stasis Dispersing therapy and to verify the traditional methods can influence the brain hematoma enlargement or not. Methods: from 2013.8 to 2015.12, 360 cases of AICH will be included in 13 research centers. Patients are randomly into 3 groups within 6hrs from onset,such as, group A, blood activating herbal medicine (8 herbals), Group B, herbal medicine without blood activating herbal(6 herbals), Group C, placebo for 10days. All the patients will be treated according AHA guideline of AICH. All patients will be set to the CT at the onset, 24h later and 10-14days after treatment. So the rate of enlargement of brain hematoma 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 Re-evaluation of Removing Blood Stasis Therapy of Herbal Medicine in Treating Acute Cerebral Hemorrhage Safety

Conditions
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Intracerebral Hemorrhage

Intervention / Treatment
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* Drug: ICH-1(herbal medicine with Hirudo, Tabanus)
* Drug: placebo
* Drug: ICH-2(herbal medicine without Hirudo, Tabanus)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no younger than 18 yrs acute cerebral hemorrhage confirmed by brain CT scan within 6 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

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: ICH-1<br>herbal medicine with Hirudo, Tabanus,8 herbals, promote blood circulation function | Drug: ICH-1(herbal medicine with Hirudo, Tabanus)<br>* 8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days<br>* Other names: PXZY;|
| Active Comparator: ICH-2<br>herbal medicine without Hirudo, Tabanus,Only 6 herbals | Drug: ICH-2(herbal medicine without Hirudo, Tabanus)<br>* (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days<br>* Other names: NPXZY;|
| Placebo Comparator: placebo herbal medicine<br>Placebo ：granula，dose twice a day by Oral or nasogastric tube for 10 days | Drug: placebo<br>* placebo herbal medicine, one dose,bid, for 10 days<br>* Other names: pxzyp;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematoma enlargement |  | 24hrs, 10-14days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatality rate |  | 3 month | 
| modified rankin scale |  | 3 months | 
| National Institute of Health of stroke scale |  | 10-14days, 90days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Activating blood stagnation and expelling blood stasis, Hematoma enlargement, herbal medicine, traditional chinese medicine, random clinical trial