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A Clinical Trial of Danhong Injection in Treating Acute Ischemic Stroke

NCT02152280 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2014-06-02

No results posted yet for this study

Summary

Research topic.

* A clinical trial of Danhong injection in treating acute ischemic stroke .

Research purpose.

\- To evaluate the efficacy and safety of Danhong injection in treating acute ischemic stroke by a randomized, double-blind, multi-center, placebo-controlled clinical trial.

Research design.

\- A randomized, double-blind, multi-center, placebo-controlled clinical trial.

Subject crowd.

\- Accord with standard of western medicine diagnosis of acute cerebral infarction, stroke and blood stasis type of traditional Chinese medicine syndrome differentiation.

Sample size. - Total sample size of 320 patients, experimental group, control group is equal to 1 to 1.

Interim analysis.

\- Interim analysis will be performed when the total number of included patients up to half of the sample size ,160 cases, and according to the interim analysis results to estimate the sample size and adjust the project adaptively.

Course of treatment.

\- 10 days.

Research endpoint.

\- The 90th day after the medication for the first time.

Observation index.

1. General condition; the physical and chemical inspection related;
2. Efficacy check : mRS, BI, NIHSS;
3. Safety check: blood routine, urine routine, stool OB, liver function(ALT、AST), renal function (BUN, Cr), coagulation four indices（PT、APTT、TT、FIB), electrocardiogram.

Efficacy evaluation. 1. The main efficacy index: a. Percentage comparisons of two group patients of modified Rankin 0-2 grades on the 90th day.

Statistical analysis technique.

\- Statistical analysis using SAS 9.2 system, all the statistical test adopted bilateral inspection, P value less than or equal to 0.05 will be considered a statistically significant difference.

Conditions

Interventions

DRUG

Danhong Injection

Danhong Injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 10 days.

DRUG

Normal Saline

0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 10 days;

Sponsors & Collaborators

  • Beijing Bozhiyin T&S Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fang D Cai, doctor · Traditional Chinese medicine department of Zhongshan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-12-31
Completion
2015-12-31

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Diseases

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 NCT02152280 on ClinicalTrials.gov