NCT01636154

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

4.2 years

First QC Date

June 29, 2012

Last Update Submit

August 4, 2016

Conditions

Ischemic Stroke

Keywords

fire-heat syndromeblood stasis syndromemethod of clearing heatmethod of promoting blood circulationmedicinal fractions-based herbal combinations

Study Arms (4)

The basic treatment

NO INTERVENTION

Comply to the Chinese guidelines of acute ischemic stroke in 2010

Clearing heat

OTHER

Treat with KDZ injection on the basis of the basic treatment

Drug: Ixeris of sonchifolia Hance

Promoting blood circulation

OTHER

Treat with Xueshuantong injection on the basis of the basic treatment

Drug: Panax notoginseng saponins

Clearing heat & Promoting blood circulation

EXPERIMENTAL

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

Interventions

Ixeris of sonchifolia HanceDRUG

KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.

Also known as: KDZ injection
Clearing heat
Panax notoginseng saponinsDRUG

Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.

Also known as: Xueshuantong injection
Promoting blood circulation
Ixeris of sonchifolia Hance combined with Panax notoginseng saponinsDRUG

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.

Clearing heat & Promoting blood circulation

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100078, China

Location

Department of Neurology,Huairou Hospital of Traditional Chinese Medicine

Beijing, Beijing Municipality, 101400, China

Location

Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, 250011, China

Location

Related Publications (1)

  • 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.

    PMID: 30245755DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Panax notoginseng extract

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yunling Zhang, PhD,MD

    Dongfang Hospital Beijing University of Chinese Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
President of of Dongfang Hospital

Study Record Dates

First Submitted

June 29, 2012

First Posted

July 10, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2016

Study Completion

August 1, 2016

Last Updated

August 5, 2016

Record last verified: 2016-08

Locations

CN(3)