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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 29, 2012

Last Updated Date

February 28, 2013

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

February 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01636154 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Ischemic Stroke

Intervention ^ICMJE

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
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
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.

Study Arm (s)

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

Intervention: Drug: Ixeris of sonchifolia Hance
Promoting blood circulation
Treat with Xueshuantong injection on the basis of the basic treatment

Intervention: Drug: Panax notoginseng saponins
Experimental: Clearing heat & Promoting blood circulation
Treat with both KDZ injection and Xueshuantong injection on the basis of the basic treatment

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

August 2016

Estimated Primary Completion Date

February 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yunling Zhang, PhD,MD

86 10 67689634

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01636154

Other Study ID Numbers ^ICMJE

BUCMDFH9634

Has Data Monitoring Committee

Yes

Responsible Party

Yunling Zhang, Dongfang Hospital

Study Sponsor ^ICMJE

Yunling Zhang

Collaborators ^ICMJE

Shandong University of Traditional Chinese Medicine
Huairou Hospital of Traditional Chinese Medicine

Investigators ^ICMJE

Study Chair:

Yunling Zhang, PhD,MD

Dongfang Hospital,Beijing University of Chinese Medicine

Information Provided By

Dongfang Hospital

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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