Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy of fractions-based herbal combinations of clearing heat and promoting blood circulation treating acute ischemic stroke and the potential mechanism of it.

Detailed Description
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The interaction between fire-heat and blood stasis is a significant mechanism underlying pathogenesis and progress in acute ischemic stroke according to TCM theory.Clinical therapeutic effects are achieved with wide application of Ixeris of sonchifolia Hance components (KDZ injection) representing method of clearing heat and Panax notoginseng saponins components (Xueshuantong injection) representing method of promoting blood circulation.

Official Title
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Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations:A Prospective Randomized Controlled Multi-site Clinical Trial About Fractions-based Herbal Combinations of Clearing Heat and Promoting Blood Circulation

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 Stoke onset within 48 hours NIHSS scores range from 5 points to 25 points Age from forty to seventy-five,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) Patients have received thrombolytic therapy Patients with serious diseases of heart,lungs,liver,kidneys Patients with bleeding or bleeding tendency recently Pregnant or lactating women Pre-existing neurological or psychiatric diseases that could confound the study results Patients be allergic to alcohol,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: 75 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 guidelines of acute ischemic stroke in 2010 | |
| Other: Clearing heat<br>Treat with KDZ injection on the basis of the 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 circulation<br>Treat with Xueshuantong injection on the basis of the 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 injection;|
| Experimental: Clearing heat & Promoting blood circulation<br>Treat with both KDZ injection and Xueshuantong injection on the basis of the basic treatment | Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins<br>* KDZ40ml+0.9%N.S.250ml,ivdrip;0.9%N.S.50ml,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 |
| --- | --- | --- |

 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, medicinal fractions-based herbal combinations