Heat-clearing and Blood-activating Chinese Medicinal Components in Acute Cerebral Infarction
1 other identifier
interventional
120
1 country
4
Brief Summary
The present study is designed to confirm the therapeutic effects of heat-clearing and blood-activating Chinese medicinal components in treatment of Acute Cerebral Infarction (ACI) and to investigate the therapeutic mechanisms of multi-target anti-inflammatory action involved from the standpoint of pathology, cell and molecular biology, as well as immunology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 5, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedJuly 31, 2017
July 1, 2017
3 years
September 5, 2015
July 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
modified Rankin scale
180 days
Secondary Outcomes (6)
Barthel index
180 days
national institute of health stroke scale
180 days
Glasgow coma scale
180 days
scores of Chinese medicine symptoms
180 days
mortality rate
180 days
- +1 more secondary outcomes
Study Arms (4)
The basic treatment
NO INTERVENTIONComply to the Chinese guidlines of acute ischemic stroke in 2014
Clearing heat
OTHERTreat with KDZ injection on the basis of basic treatment
Promoting blood circulaton
OTHERTreat with Xueshuantong injection on the basis of basic treatment
Clearing heat&Promoting blood circulaton
EXPERIMENTALTreat with both KDZ injection and Xueshuantong injection on the basis of basic treatment
Interventions
KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
KDZ40ml+0.9%N.S.250ml,ivdrip;Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
Eligibility Criteria
You may qualify if:
- Patients with acute ischemic stroke
- Patients with fire-heat syndrome
- Stroke onset within 48 hours
- NIHSS scores range from 5 points to 25 points
- Age from forty to eighty,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),or have recieved thrombolytic therapy
- Patients suitable for endovascular therapy,or have recieved endovascular therapy
- Patients with serious disease of heart,lungs,liver or kidneys（The value of ALT or AST is more than 2 times of the upper limit of normal range,the value of creatinine is more than 1.5 times of the upper limit of normal range，asthma or COPD,or cardiac function level 4）
- Patients with bleeding or bleeding tendency recently
- Pregnant or lactating women
- Pre-existing limb dysfunction, psychiatric diaseses，or cognitive dysfunction that could confound the study results
- Patients with allergic constitutions,or have the contraindication of 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
- Yunling Zhanglead
- Shandong University of Traditional Chinese Medicinecollaborator
- Huairou Hospital of Traditional Chinese Medicinecollaborator
Study Sites (4)
Department of Neurology,Dongfang Hospital
Beijing, Beijing Municipality, 100078, China
Department of Neurology,Huairou Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, 101400, China
Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250011, China
Department of Neurology,Wuqing Hospital of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 301700, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yunling Zhang, PhD,MD
Dongfang Hospital Beijing University of Chinese Medicine
Central Study Contacts
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 Dongfang Hospital
Study Record Dates
First Submitted
September 5, 2015
First Posted
September 9, 2015
Study Start
April 1, 2015
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
July 31, 2017
Record last verified: 2017-07