Danhong Injection in the Treatment of Acute Ischemic Stroke

NCT01677208 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1503

Last updated 2022-06-08

No results posted yet for this study

Summary

The purpose of this study is to determine whether Danhong injection is effective in the treatment of acute ischemic stroke.

Conditions

  • Acute Stroke

Interventions

DRUG

Danhong injection

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

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.

Sponsors & Collaborators

  • China Food and Drug Administration

    collaborator OTHER_GOV
  • China Academy of Chinese Medical Sciences

    lead OTHER

Principal Investigators

  • Zhong Wang, Professor · Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

  • Xing-quan Zhao, Professor · Beijing Tiantan Hospital

  • Yong-yan Wang, Professor · Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

  • Xiao-xi Du, Professor · China Food and Drug Administration

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-13
Primary Completion
2019-03-10
Completion
2019-03-27

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01677208 on ClinicalTrials.gov