Atrial Premature Beats Clinical Trial
Official title:
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.
Research purpose： 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.
Research design： A randomized, double-blind, two dose group, parallel-control multi-center,
post-marketing clinical trial.
Sample size:
A total of 288 subjects, 144cases in each group.
Therapeutic schedule:
1. Low dose group (the original quantity Wenxin keli): specification 10g /bag, Wenxin keli
(no sugar) 5 g+ Wenxin keli simulation agent 5g.
2. High dose group(2 times the amount of Wenxin keli): specification 10g /bag, Wenxin keli
(no sugar) 10 g.
Usage and Dosage:
Oral ,1bag each time, 3 times a day, 4 weeks for 1 course of treatment.
Drug combination:
During the test shall not merge the other anti-arrhythmic drugs beyond the provisions of
this scheme. Due to merger disease or condition changes ,have to use drugs or other
treatment, investigators must record the types (or other treatment ),drug usage, time and
reasons, in order to summarize ,analyze and report.
Primary indicator:
24 h dynamic electrocardiogram (Holter): before treatment, after treatment of 4 w, each
record at a time.
Secondary Indicator:
Symptom scores: before treatment, after treatment of 4 w, each record at a time.
Security index:
1. Vital signs: before treatment, after treatment of 4 w, each record at a time.
2. Blood, urine, stool occult blood ,liver and kidney function, blood coagulation four,
electrolyte examination, electrocardiogram(ecg): before treatment, after treatment of 4
w, each record at a time.
Main efficacy:
Holter efficient curative effect (main efficacy index) Effective: premature beat frequency
reduced 50% or more before taking the medicine.
Invalid: no effective standard.
Secondary efficacy:
Symptom scores curative effect Effective:symptoms improve symptoms(drop 1or above) Invalid:
no effective standard.
Statistic analysis:
Main efficacy index by means of FAS,PPS analysis ,safety index SS set analysis.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment