A Clinical Trial of Danhong Injection in Treating Acute Ischemic Stroke
Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
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.