Completed

A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Acute Ischemic Stroke

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Danhong injection

+ Standard medical care

+ Standard medical care

DrugProcedure
Who is being recruted

Brain Diseases+5

+ Cardiovascular Diseases

+ Central Nervous System Diseases

From 18 to 70 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorChina Academy of Chinese Medical Sciences
Last updated: June 8, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: March 13, 2013

Actual date on which the first participant was enrolled.

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

NCT01677208
Principal SponsorChina Academy of Chinese Medical Sciences
Last updated: June 8, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1503 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesIschemic StrokeStroke

Criteria

8 inclusion criteria required to participate
4 <= NIHSS < 20
Age: 18 - 70 years
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
Clinical diagnosis of cerebral anterior circulation obstruction
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17 exclusion criteria prevent from participating
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)
Complicated with atrial fibrillation
Evidence of intracranial hemorrhage (ICH) or other cerebral diseases (eg.vascular malformation, tumor, abscess or multiple sclerosis etc.)on the CT-or MRI-scan
Hemorrhagic tendency or recent severe or dangerous bleeding in 3 months
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 62 locations

The Second Artillery General Hospital of Chinese People's Liberation Army

Beijing, ChinaOpen The Second Artillery General Hospital of Chinese People's Liberation Army in Google Maps

Xinqiao Hospital of Third Military Medical University

Chongqing, China

Chongqing Three Gorges Central Hospital

Chongqing, China

Guangdong No.2 Provincial People's Hospital

Guangzhou, China
Completed62 Study Centers