A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections
This study is to evaluate the safety and tolerability and to characterize the pharmacokinetics of multiple ascending dose (MAD) of LY03003 following intramuscular injections.
A Randomized, Double-blind, Two Dose Group, Parallel-control Multi-center, Post-marketing Clinical Trial,to Evaluate the Efficacy and Safety of Wenxin Keli in Treating Atrial Premature Beats.
A randomized, double-blind, two dose group, parallel-control multi-center, post-marketing clinical trial,to evaluate the efficacy and safety of Wenxin keli in treating atrial premature beats by different dose,to provide a scientific basis for rational clinical use of drug.
A Clinical Trial of Danhong Injection in Treating Acute Ischemic Stroke
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.
General condition; the physical and chemical inspection related;
Efficacy check : mRS, BI, NIHSS;
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.
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