Clinical trial NCT02544087: Heat-clearing and Blood-activating Chinese Medicinal Components in Acute Cerebral Infarction
Official title: Heat-clearing and Blood-activating Chinese Medicinal Components in Acute Cerebral Infarction: Mechanisms of Multi-target Anti-inflammatory Action
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Keywords: fire-heat syndrome
blood stasis syndrome
method of clearing heat
method of promoting blood circulation
Lead sponsor: Dongfang Hospital Beijing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shandong University of Traditional Chinese Medicine
name: Huairou Hospital of Traditional Chinese Medicine
First posted: 2015-09-09
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 of"cerebral 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.

Eligibility criteria: 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

Primary outcomes:
measure: modified Rankin scale
timeFrame: 180 days
Secondary outcomes:
measure: Barthel index
timeFrame: 180 days
measure: national institute of health stroke scale
timeFrame: 180 days
measure: Glasgow coma scale
timeFrame: 180 days
measure: scores of Chinese medicine symptoms
timeFrame: 180 days
measure: mortality rate
timeFrame: 180 days
measure: disability rate
timeFrame: 180 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Neurology,Dongfang Hospital
state: Beijing
city: Beijing
country: China
facility: Department of Neurology,Huairou Hospital of Traditional Chinese Medicine
state: Beijing
city: Jinan
country: China
facility: Department of Neurology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine
state: Shandong
city: Tianjin
country: China
facility: Department of Neurology,Wuqing Hospital of Traditional Chinese Medicine
state: Tianjin
Study officials:
affiliation: Dongfang Hospital Beijing University of Chinese Medicine
name: Yunling Zhang, PhD,MD
role: STUDY_CHAIR
References: