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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ixeris of sonchifolia Hance
Panax notoginseng saponins
Ixeris of sonchifolia Hance combined with Panax notoginseng saponins
Sponsored by
Yunling Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring fire-heat syndrome, blood stasis syndrome, method of clearing heat, method of promoting blood circulation, medicinal fractions-based herbal combinations

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine
  • Department of Neurology,Huairou Hospital of Traditional Chinese Medicine
  • Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Other

Other

Experimental

Arm Label

The basic treatment

Clearing heat

Promoting blood circulation

Clearing heat & Promoting blood circulation

Arm Description

Comply to the Chinese guidelines of acute ischemic stroke in 2010

Treat with KDZ injection on the basis of the basic treatment

Treat with Xueshuantong injection on the basis of the basic treatment

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 29, 2012
Last Updated
August 4, 2016
Sponsor
Yunling Zhang
Collaborators
Shandong University of Traditional Chinese Medicine, Huairou Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01636154
Brief Title
Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yunling Zhang
Collaborators
Shandong University of Traditional Chinese Medicine, Huairou Hospital of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
fire-heat syndrome, blood stasis syndrome, method of clearing heat, method of promoting blood circulation, medicinal fractions-based herbal combinations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The basic treatment
Arm Type
No Intervention
Arm Description
Comply to the Chinese guidelines of acute ischemic stroke in 2010
Arm Title
Clearing heat
Arm Type
Other
Arm Description
Treat with KDZ injection on the basis of the basic treatment
Arm Title
Promoting blood circulation
Arm Type
Other
Arm Description
Treat with Xueshuantong injection on the basis of the basic treatment
Arm Title
Clearing heat & Promoting blood circulation
Arm Type
Experimental
Arm Description
Treat with both KDZ injection and Xueshuantong injection on the basis of the basic treatment
Intervention Type
Drug
Intervention Name(s)
Ixeris of sonchifolia Hance
Other Intervention Name(s)
KDZ injection
Intervention Description
KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
Intervention Type
Drug
Intervention Name(s)
Panax notoginseng saponins
Other Intervention Name(s)
Xueshuantong injection
Intervention Description
Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
Intervention Type
Drug
Intervention Name(s)
Ixeris of sonchifolia Hance combined with Panax notoginseng saponins
Intervention Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunling Zhang, PhD,MD
Organizational Affiliation
Dongfang Hospital Beijing University of Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100078
Country
China
Facility Name
Department of Neurology,Huairou Hospital of Traditional Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101400
Country
China
Facility Name
Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250011
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
30245755
Citation
Liu X, Jin X, Chen B, Liu X, Liang X, Fang X, Wu H, Fu X, Zheng H, Ding X, Duan N, Zhang Y. Effects of Kudiezi Injection on Serum Inflammatory Biomarkers in Patients with Acute Cerebral Infarction. Dis Markers. 2018 Sep 2;2018:7936736. doi: 10.1155/2018/7936736. eCollection 2018.
Results Reference
derived

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

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