Clinical trial NCT01636154: Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations
Official title: Clinical Application and Basic Study of Medicinal Fractions-based Herbal Combinations:A Prospective Randomized Controlled Multi-site Clinical Trial About Fractions-based Herbal Combinations of Clearing Heat and Promoting Blood Circulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: fire-heat syndrome
blood stasis syndrome
method of clearing heat
method of promoting blood circulation
medicinal fractions-based herbal combinations
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: 2012-07-10
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Detailed description: The interaction between fire-heat and blood stasis is a significant mechanism underlying pathogenesis and progress in acute ischemic stroke according to TCM theory.Clinical therapeutic effects are achieved with wide application of Ixeris of sonchifolia Hance components (KDZ injection) representing method of clearing heat and Panax notoginseng saponins components (Xueshuantong injection) representing method of promoting blood circulation.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine
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
Study officials:
affiliation: Dongfang Hospital Beijing University of Chinese Medicine
name: Yunling Zhang, PhD,MD
role: STUDY_CHAIR
References:
citation: 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.