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

August 4, 2016 updated by: Yunling Zhang

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100078
        • Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine
      • Beijing, Beijing, China, 101400
        • Department of Neurology,Huairou Hospital of Traditional Chinese Medicine
    • Shandong
      • Jinan, Shandong, China, 250011
        • Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: The basic treatment
Comply to the Chinese guidelines of acute ischemic stroke in 2010
Other: 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 Names:
  • KDZ injection
Other: 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 Names:
  • 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yunling Zhang

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

June 29, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (Estimate)

July 10, 2012

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUCMDFH9634

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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