We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636154
First Posted: July 10, 2012
Last Update Posted: August 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Shandong University of Traditional Chinese Medicine
Huairou Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Yunling Zhang, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
  Purpose
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.

Condition Intervention
Ischemic Stroke Drug: Ixeris of sonchifolia Hance Drug: Panax notoginseng saponins Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Yunling Zhang, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine:

Enrollment: 120
Study Start Date: January 2012
Study Completion Date: August 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: The basic treatment
Comply to the Chinese guidelines of acute ischemic stroke in 2010
Clearing heat
Treat with KDZ injection on the basis of the basic treatment
Drug: Ixeris of sonchifolia Hance
KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
Other Name: KDZ injection
Promoting blood circulation
Treat with Xueshuantong injection on the basis of the basic treatment
Drug: Panax notoginseng saponins
Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
Other Name: Xueshuantong injection
Experimental: Clearing heat & Promoting blood circulation
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
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.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636154


Locations
China, Beijing
Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine
Beijing, Beijing, China, 100078
Department of Neurology,Huairou Hospital of Traditional Chinese Medicine
Beijing, Beijing, China, 101400
China, Shandong
Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China, 250011
Sponsors and Collaborators
Yunling Zhang
Shandong University of Traditional Chinese Medicine
Huairou Hospital of Traditional Chinese Medicine
Investigators
Study Chair: Yunling Zhang, PhD,MD Dongfang Hospital,Beijing University of Chinese Medicine
  More Information

Responsible Party: Yunling Zhang, President of of Dongfang Hospital, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT01636154     History of Changes
Other Study ID Numbers: BUCMDFH9634
First Submitted: June 29, 2012
First Posted: July 10, 2012
Last Update Posted: August 5, 2016
Last Verified: August 2016

Keywords provided by Yunling Zhang, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine:
fire-heat syndrome
blood stasis syndrome
method of clearing heat
method of promoting blood circulation
medicinal fractions-based herbal combinations