Trial | NCT01636154  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ginseng ixeris of sonchifolia hance ...

  • Study Participants

    120
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.
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.
Study Started
Jan 31
2012
Primary Completion
Mar 31
2016
Study Completion
Aug 31
2016
Last Update
Aug 05
2016
Estimate

Drug Ixeris of sonchifolia Hance

KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.

  • Other names: KDZ injection

Drug Panax notoginseng saponins

Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.

  • Other names: Xueshuantong injection

Drug Ixeris of sonchifolia Hance combined with Panax notoginseng saponins

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.

The basic treatment No Intervention

Comply to the Chinese guidelines of acute ischemic stroke in 2010

Clearing heat Other

Treat with KDZ injection on the basis of the basic treatment

Promoting blood circulation Other

Treat with Xueshuantong injection on the basis of the basic treatment

Clearing heat & Promoting blood circulation Experimental

Treat with both KDZ injection and Xueshuantong injection on the basis of the basic treatment

Criteria 

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
No Results Posted