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

NCT02176395 | Completed Phase 4 DMC

• 1 other identifier: DH20140604
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Acute Stroke

Keywords

Acute Ischemic Stroke; Randomized Controlled Trial; Traditional Chinese Medicine; Proteomics

Outcome Measures

Primary Outcomes (1)

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

  Day 90

Other Outcomes (4)

• The changes of serum proteomics in 36 patients selected from certain center

  Day 0, Day 14, Day 90

• The microRNA profile in 10 healthy volunteer

  Day0

• The mRNA profiles in 10 healthy volunteer

  Day0

Study Arms (3)

Danhong injection

EXPERIMENTAL

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; Procedure: Standard medical care

placebo

PLACEBO COMPARATOR

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

healthy volunteer

NO INTERVENTION

Interventions

Danhong injection DRUG

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

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

Danhong injection

Standard medical care PROCEDURE

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.

Danhong injection; placebo

placebo DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead
• China Food and Drug Administration: collaborator

Study Sites (4)

Nanshi Hospital of Nanyang

Nanyang, Henan, 473065, China

Location

Panjin Central Hospital

Panjin, Liaoning, 124013, China

Location

202 Military Hospital of China

Shenyang, Liaoning, China

Location

Affiliated Hospital of Chifeng University

Chifeng, Neimenggu, 024005, China

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

danhong; Honghua extract, Carthamus tinctorius

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wang Zhong, Professor

  Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

• Zhao Xingquan, Professor

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Wang Yongyan, Professor

  Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

  STUDY CHAIR

• Jiang Zhilin, Professor

  202 Military Hospital of China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: July 1, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

CN (4)