Ischemic Stroke
Conditions
Keywords
fire-heat syndrome, blood stasis syndrome, method of clearing heat, method of promoting blood circulation
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.
Detailed description
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. In particular, investigators choose heat-clearing Ixeris of sonchifolia Hance(Kudiezi Injection) and blood-activating Panax notoginseng saponins(Xueshuantong Injection)as the therapeutic interventions to carry out the investigation, applying the key techniques such as Lentivirus-mediated RNA interference, co-immunoprecipitation and immunomagnetic beads. With the joint efforts, investigators hope to find out the combined therapeutic targets based on better understanding of the inflammatory pathology in ACI and illuminate the synergistic mechanisms involved, which may validate the Chinese medicine theory ofcerebral vascular damage due to heat toxicity in the pathogenesis of ACI and yield new therapeutic strategies for ACI. As an international science and technology cooperation project, the study is of great significance in establishing an international technology platform of intervention target system for the treatment of ACI; moreover, it marks a key step forward for China to enhance China's international brands through exploring a successful mode of foreign cooperation in Chinese medicine.
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.
Sponsors
Shandong University of Traditional Chinese Medicine
Huairou Hospital of Traditional Chinese Medicine
Yunling Zhang
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| modified Rankin scale | 180 days |
Secondary
| Measure | Time frame |
|---|---|
| Barthel index | 180 days |
| national institute of health stroke scale | 180 days |
| mortality rate | 180 days |
| scores of Chinese medicine symptoms | 180 days |
| disability rate | 180 days |
| Glasgow coma scale | 180 days |
Countries
China
Contacts
Primary ContactZhang, PhD,MD
Outcome results
None listed