Clinical trial NCT02176395: Multi-"Omics" Research of Danhong Injection to Treat Acute Ischemic Stroke
Official title: Multi-"Omics" Research of Danhong Injection to Treat Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Stroke
Keywords: Acute Ischemic Stroke
Randomized Controlled Trial
Traditional Chinese Medicine
Proteomics
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: China Food and Drug Administration
First posted: 2014-06-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to explore the pharmacological mechanism of Danhong injection in the treatment of acute ischemic stroke.


Eligibility criteria: Inclusion Criteria:

1. Female or male inpatients

   * Age: 18 - 70 years.
   * Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes hemorrhage.
   * Clinical diagnosis of "Xueyu Zheng" (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of "Xueyu Zheng" in ischemic stroke ≥ 20. The Chinese medicine symptoms scales of "Xueyu Zheng" is defined as following (1)hemiplegia-10,(2)numbness of limbs-10，(3) dark face-9,(4)purple or dark lip-8,(5)Roughness of skin-4, (6) pain with fixed point-5, (7) purple or dark tongue-10,(8)ecchymosis on tongue-10,(9)purple sublingual vessel-10,(10)varicose sublingual vessel-8,(11)unsmooth pulse-8,(12)intermittent pulse-1.
   * Onset of symptoms in 1 week prior to initiation of administration of study drug.
   * Clinical diagnosis of cerebral anterior circulation obstruction.
   * 4≤NIHSS\<20.
   * Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating centers.
2. Female or male healthy volunteer

   * Age: 18 - 70 years.
   * Medical history, physical examination, vital signs, electrocardiogram(ECG) and laboratory results (including renal function, hepatic function, et al)with no clinically significant findings.
   * Healthy volunteer is willing to participate voluntarily and to sign a written informed consent form. Informed consent will be obtained from each volunteer, according to the regulatory and legal requirements of the participating centers.

Exclusion Criteria:

1. Female or male inpatients

   * Evidence of intracranial hemorrhage (ICH) or other cerebral diseases (eg.vascular malformation, tumor, abscess or multiple sclerosis etc.)on the CT-or MRI-scan.
   * Patients with thrombolysis or endovascular treatment.
   * Known history of allergy or suspected allergic to the drug.
   * Blood glucose 2.8 or \> 16.8 mmol / l under the treatment of diabetes or with severe complications due to diabetes (eg. peripheral neuropathy, diabetic gangrene).
   * Liver function impairment with the value of ALT or AST over 1.5-fold of normal value.
   * Renal dysfunction with the value of serum creatinine over 1.5-fold of normal value.
   * Severe cardiac dysfunction on echocardiogram or the grade of heart function over Ⅲ grade.
   * History of prior stroke with mRS ≥2.
   * Complicated with atrial fibrillation.
   * Severe stroke as assessed by appropriate imaging techniques (eg. massive cerebral infarction including more than one lobe of brain or over 1/3 of blood-supply area of middle cerebral artery).
   * Prior disable patients.
   * Hemorrhagic tendency or recent severe or dangerous bleeding in 3 months.
   * Suspected addicted into alcohol or drug abuse.
   * With severe complications that would make the condition more complicated assessed by the investigator.
   * Woman with pregnancy, lactation or positive result of pregnancy test, or women who want to be pregnant in recent 6 months.
   * Woman who is under menstrual period.
   * Patient who is participating in other trials or has been participated in other trials in recent 3 months.
2. Healthy volunteer

   * Had a known history of chronic diseases including stroke, heart diseases, diabetes, COPD, Neuropsychiatric diseases and chronic infectious diseases, etc.
   * Coagulation disorders.
   * Conditions with increased bleeding risk.
   * Trauma or surgery in the 6 months prior to the study.
   * Use of any medication 4 weeks prior to the trial.
   * History of drug abuse.

Primary outcomes:
measure: Modified Rankin Scale 0-1 (favourable outcome) at Day 90
timeFrame: Day 90
Secondary outcomes:
Other outcomes:
measure: The changes of serum proteomics in 36 patients selected from certain center
timeFrame: Day 0, Day 14, Day 90
measure: The microRNA profile in 10 healthy volunteer
timeFrame: Day0
measure: The mRNA profiles in 10 healthy volunteer
timeFrame: Day0
measure: The proteomics profiles of 10 healthy volunteer
timeFrame: Day 0
Locations:
city: Nanyang
country: China
facility: Nanshi Hospital of Nanyang
state: Henan
city: Panjin
country: China
facility: Panjin Central Hospital
state: Liaoning
city: Shenyang
country: China
facility: 202 Military Hospital of China
state: Liaoning
city: Chifeng
country: China
facility: Affiliated Hospital of Chifeng University
state: Neimenggu
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Wang Zhong, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Zhao Xingquan, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Wang Yongyan, Professor
role: STUDY_CHAIR
affiliation: 202 Military Hospital of China
name: Jiang Zhilin, Professor
role: PRINCIPAL_INVESTIGATOR
References: