Multi-"Omics" Research of Danhong Injection to Treat Acute Ischemic Stroke

Sponsor

China Academy of Chinese Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02176395

Collaborator

China Food and Drug Administration (Other)

Enrollment

Locations

Arms

Duration (Months)

11.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Stroke	Drug: Danhong injection Procedure: Standard medical care Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Multi-"Omics" Research of Danhong Injection to Treat Acute Ischemic Stroke

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Danhong injection Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.	Drug: Danhong injection 40ml Danhong injection added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion Other Names: A kind of injection made from two kind of Chinese herbs: Salvia miltiorrhiza and Safflower. Procedure: Standard medical care Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2010), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.
Placebo Comparator: placebo Based on the standard medical care, 40ml of 0.9% saline as the placebo, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.	Procedure: Standard medical care Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2010), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care. Drug: placebo 0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion
No Intervention: healthy volunteer

Arm

Intervention/Treatment

Experimental: Danhong injection

Based on the standard medical care, 40ml of Danhong injection, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.

Drug: Danhong injection

40ml Danhong injection added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion

Other Names:

A kind of injection made from two kind of Chinese herbs: Salvia miltiorrhiza and Safflower.

Procedure: Standard medical care

Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2010), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.

Placebo Comparator: placebo

Based on the standard medical care, 40ml of 0.9% saline as the placebo, added into 250ml of 0.9% saline, given by continuous IV infusion at 2.5ml/min within 2 hours.

Procedure: Standard medical care

Drug: placebo

0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion

No Intervention: healthy volunteer

Outcome Measures

Primary Outcome Measures

Modified Rankin Scale 0-1 (favourable outcome) at Day 90 [Day 90]

Other Outcome Measures

The changes of serum proteomics in 36 patients selected from certain center [Day 0, Day 14, Day 90]
We wish to identify protein biomarkers in the blood that changed with Danhong treatment
The microRNA profile in 10 healthy volunteer [Day0]
The mRNA profiles in 10 healthy volunteer [Day0]
The proteomics profiles of 10 healthy volunteer [Day 0]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

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:

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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanshi Hospital of Nanyang	Nanyang	Henan	China	473065
2	Panjin Central Hospital	Panjin	Liaoning	China	124013
3	202 Military Hospital of China	Shenyang	Liaoning	China
4	Affiliated Hospital of Chifeng University	Chifeng	Neimenggu	China	024005

Sponsors and Collaborators

China Academy of Chinese Medical Sciences
China Food and Drug Administration

Investigators

Principal Investigator: Wang Zhong, Professor, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Principal Investigator: Zhao Xingquan, Professor, Beijing Tiantan Hospital
Study Chair: Wang Yongyan, Professor, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Principal Investigator: Jiang Zhilin, Professor, 202 Military Hospital of China