Overview

A Clinical Trial of Danhong Injection in Treating Acute Ischemic Stroke

Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing Bozhiyin T&S Co., Ltd.
Treatments:
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- Accord with the diagnostic criteria of cerebral infarction of "Guide of diagnosis and
treatment of acute ischemic stroke in China" in 2010, and in the acute stage;

- Accord with the stroke and blood stasis type;

- Onset of acute ischemic stroke within 72 hours;

- NIHSS grade ≥ 4;

- Age ≥ 18;

- signed the inform consent form.

Exclusion Criteria:

- Diagnosed with bleeding or other pathological brain disorders according to CT or MRI
at baseline , such as vascular malformation, tumor, abscess or other common non
ischemic cerebral disease (for multiple sclerosis);

- Patients with hrombolysis or endovascular treatment;

- Allergic constitution; the test drug allergy or its ingredients or elements allergy;

- With severe liver function damage(ALT and AST level more than 1.5 times higher than
normal);

- With severe renal impairment (more than 1.5 times higher than normal amount of serum
creatinine);

- With severe cardiac insufficiency (cardiac function rating level III above)

- Disabled patients of law (blind, deaf, dumb, mental retardation, mental disorder and
physical disabilities caused by other reasons which affects the nerve function defect
evaluation);

- With bleeding tendency or had serious bleeding within 3 months;

- Doubted or had alcohol and drug abuse history; Or who will lower the possibilities of
enrollment or complicate the enrollment according to the investigaters' judgement;

- Menstrual period women, pregnant women and lactating women, pregnancy test positive or
recent family planning;

- Who being in other clinical trials or had finished other clinical trials within 3
months.