Heat-clearing and Blood-activating Chinese Medicinal Components in Acute Cerebral Infarction

Study Overview
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Brief Summary
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The present study is designed to confirm the therapeutic effects of heat-clearing and blood-activating Chinese medicinal components in treatment of Acute Cerebral Infarction (ACI) and to investigate the therapeutic mechanisms of multi-target anti-inflammatory action involved from the standpoint of pathology, cell and molecular biology, as well as immunology.

Detailed Description
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The present study is designed to confirm the therapeutic effects of heat-clearing and blood-activating Chinese medicinal components in treatment of Acute Cerebral Infarction (ACI) and to investigate the therapeutic mechanisms of multi-target anti-inflammatory action involved from the standpoint of pathology, cell and molecular biology, as well as immunology. In particular, investigators choose heat-clearing Ixeris of sonchifolia Hance(Kudiezi Injection) and blood-activating Panax notoginseng saponins(Xueshuantong Injection)as the therapeutic interventions to carry out the investigation, applying the key techniques such as Lentivirus-mediated RNA interference, co-immunoprecipitation and immunomagnetic beads. With the joint efforts, investigators hope to find out the combined therapeutic targets based on better understanding of the inflammatory pathology in ACI and illuminate the synergistic mechanisms involved, which may validate the Chinese medicine theory ofcerebral vascular damage due to heat toxicity in the pathogenesis of ACI and yield new therapeutic strategies for ACI. As an international science and technology cooperation project, the study is of great significance in establishing an international technology platform of intervention target system for the treatment of ACI; moreover, it marks a key step forward for China to enhance China's international brands through exploring a successful mode of foreign cooperation in Chinese medicine.

Official Title
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Heat-clearing and Blood-activating Chinese Medicinal Components in Acute Cerebral Infarction: Mechanisms of Multi-target Anti-inflammatory Action

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Ixeris of sonchifolia Hance
* Drug: Panax notoginseng saponins
* Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute ischemic stroke Patients with fire-heat syndrome Stroke onset within 48 hours NIHSS scores range from 5 points to 25 points Age from forty to eighty,gender not limited Informed and signed the consent Exclusion Criteria: Cardiogenic cerebral embolism,stroke caused by other reasons or the unexplained Patients suitable for thrombolytic therapy(rt-PA,urokinase),or have recieved thrombolytic therapy Patients suitable for endovascular therapy,or have recieved endovascular therapy Patients with serious disease of heart,lungs,liver or kidneys（The value of ALT or AST is more than 2 times of the upper limit of normal range,the value of creatinine is more than 1.5 times of the upper limit of normal range，asthma or COPD,or cardiac function level 4） Patients with bleeding or bleeding tendency recently Pregnant or lactating women Pre-existing limb dysfunction, psychiatric diaseses，or cognitive dysfunction that could confound the study results Patients with allergic constitutions,or have the contraindication of Ixeris of sonchifolia Hance components(KDZ injection) or Panax notoginseng saponins components(Xueshuantong injection) Patients have participated in other clinical trials within 3 months

Ages Eligible for Study
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Minimum Age: 40 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: The basic treatment<br>Comply to the Chinese guidlines of acute ischemic stroke in 2014 | |
| Other: Clearing heat<br>Treat with KDZ injection on the basis of basic treatment | Drug: Ixeris of sonchifolia Hance<br>* KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.<br>* Other names: KDZ injection;|
| Other: Promoting blood circulaton<br>Treat with Xueshuantong injection on the basis of basic treatment | Drug: Panax notoginseng saponins<br>* Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.<br>* Other names: Xueshuantong injections;|
| Experimental: Clearing heat&Promoting blood circulaton<br>Treat with both KDZ injection and Xueshuantong injection on the basis of basic treatment | Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins<br>* KDZ40ml+0.9%N.S.250ml,ivdrip;Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin scale |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel index |  | 180 days | 
| national institute of health stroke scale |  | 180 days | 
| Glasgow coma scale |  | 180 days | 
| scores of Chinese medicine symptoms |  | 180 days | 
| mortality rate |  | 180 days | 
| disability rate |  | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fire-heat syndrome, blood stasis syndrome, method of clearing heat, method of promoting blood circulation