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A Randomized, double-blind, placebo-controlled, four dose groups, post-marketing clinical trial, to evaluate the efficacy and safety of Wenxin granules in treating atrial premature beats by different doses,to provide a scientific basis for rational clinical use of drug.
Full description
Research purpose: To evaluate the efficacy and safety of Wenxin granules in treating atrial premature beats by different doses, to provide a scientific basis for rational clinical use of drug.
Research design: A Randomized, double-blind, placebo-controlled, four dose groups, post-marketing clinical trial.
Sample size:
The ratio of high, medium and low dose groups and placebo group were 1:1:1:1. A total of 60 cases were included in the first phase.The maximum sample size required was determined to be 150 cases.
Therapeutic schedule:
Usage and Dosage:The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
Drug combination:
During the test should 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 Outcome Measures
Time Frame: Week 0 to Week 4
Secondary Outcome Measures
Change in Total Score From Baseline in Traditional Chinese Medicine Syndrome Score Scale (TCMSSS).
Time Frame: Week 0 to Week 4
Responder rate based on each symptom score, defined as the proportion (%) of subjects with a ≥ 1 score reduction in each symptom score from baseline.
Time Frame: Week 0 to Week 4
Other Outcome Measures
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Interventional model
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150 participants in 4 patient groups, including a placebo group
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Central trial contact
Haixia Li; Hongli Wu
Data sourced from clinicaltrials.gov
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