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

Recruiting

Phase N/A Results N/A

Trial Description

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

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 of"cerebral 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.

Conditions

Interventions

  • Ixeris of sonchifolia Hance Drug
    Other Names: KDZ injection
    Intervention Desc: KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
    ARM 1: Kind: Experimental
    Label: Clearing heat
    Description: Treat with KDZ injection on the basis of basic treatment
  • Panax notoginseng saponins Drug
    Other Names: Xueshuantong injections
    Intervention Desc: Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
    ARM 1: Kind: Experimental
    Label: Promoting blood circulaton
    Description: Treat with Xueshuantong injection on the basis of basic treatment
  • Ixeris of sonchifolia Hance combined with Panax notoginseng saponins Drug
    Intervention Desc: KDZ40ml+0.9%N.S.250ml,ivdrip;Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
    ARM 1: Kind: Experimental
    Label: Clearing heat&Promoting blood circulaton
    Description: Treat with both KDZ injection and Xueshuantong injection on the basis of basic treatment

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Factorial Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary modified Rankin scale 180 days No
Secondary Barthel index 180 days No
Secondary national institute of health stroke scale 180 days No
Secondary Glasgow coma scale 180 days No
Secondary Chinese medicine syndrome 180 days No
Secondary mortality rate 180 days No
Secondary disability rate 180 days No
Secondary scores of Chinese medicine symptoms 180 days No

Sponsors