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

This study is currently recruiting participants.
Verified February 2013 by Dongfang Hospital
Sponsor:
Collaborators:
Shandong University of Traditional Chinese Medicine
Huairou Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Yunling Zhang, Dongfang Hospital
ClinicalTrials.gov Identifier:
NCT01636154
First received: June 29, 2012
Last updated: February 28, 2013
Last verified: February 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dongfang Hospital:

Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: February 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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636154

Contacts
Contact: Yunling Zhang, PhD,MD 86 10 67689634

Locations
China, Beijing
Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine Active, not recruiting
Beijing, Beijing, China, 100078
Department of Neurology,Huairou Hospital of Traditional Chinese Medicine Active, not recruiting
Beijing, Beijing, China, 101400
China, Shandong
Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine Recruiting
Jinan, Shandong, China, 250011
Contact: Xianghua Qi       qixianghua2005@163.com   
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

No publications provided

Responsible Party: Yunling Zhang, President of of Dongfang Hospital, Dongfang Hospital
ClinicalTrials.gov Identifier: NCT01636154     History of Changes
Other Study ID Numbers: BUCMDFH9634
Study First Received: June 29, 2012
Last Updated: February 28, 2013
Health Authority: China: Ministry of Science and Technology

Keywords provided by Dongfang Hospital:
fire-heat syndrome
blood stasis syndrome
method of clearing heat
method of promoting blood circulation
medicinal fractions-based herbal combinations

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014