Heat-clearing and Blood-activating Chinese Medicinal Components in Acute Cerebral Infarction

Yunling Zhang

Status: Unknown

Conditions: Ischemic Stroke

Treatments: Drug: Panax notoginseng saponins; Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins; Drug: Ixeris of sonchifolia Hance

Study type: Interventional

Funder types: Other

Identifiers

NCT02544087

2015DFA31130

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

The basic treatment

No Intervention group

Description:

Comply to the Chinese guidlines of acute ischemic stroke in 2014

Clearing heat

Other group

Description:

Treat with KDZ injection on the basis of basic treatment

Treatment:

Drug: Ixeris of sonchifolia Hance

Promoting blood circulaton

Other group

Description:

Treat with Xueshuantong injection on the basis of basic treatment

Treatment:

Drug: Panax notoginseng saponins

Clearing heat&Promoting blood circulaton

Experimental group

Description:

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

Treatment:

Drug: Ixeris of sonchifolia Hance combined with Panax notoginseng saponins