The Dose-Effect Relationship of Wenxin Granules in the Treatment of Atrial Premature Beats (NCT04163835) | Clinical Trial Compass
UnknownPhase 4
The Dose-Effect Relationship of Wenxin Granules in the Treatment of Atrial Premature Beats
China150 participantsStarted 2015-09-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Accord with the diagnostic criteria of arrhythmia (atrial premature beats );
✓. Accord with the diagnostic criteria of deficiency of both qi and yin and heart vessel stasis and obstruction Syndrome;
✓. The number of premature beat of 24 h dynamic electrocardiogram \>360 times/h or \>8640 times/24h;
✓. Stop using the anti- arrhythmic drugs for more than five half-life (except that who long-term (one month or more) with beta blockers for high blood pressure and exertional angina);
✓. Ages 18 to 75 years old ,all genders;
✓. Voluntary subjects and signed the informed consent form.
Exclusion criteria
✕. Serious condition that need to merge other anti-arrhythmic drugs(I,II,III,IV) to treat;
✕. Heart rhythm disorders caused by the factors such as drugs ,electrolyte and acid-base balance disorders;
✕. Merge tardy arrhythmia (including sick sinus syndrome and II degree atrioventricular block);
✕. Removed predisposing factors (such as fatigue, nervousness, mood swings, alcoholism, etc.) the premature beats reduced, while the symptoms significantly relieved;
✕. Patients who have pacemaker implanted or have undergone heart percutaneous coronary intervention (PCI) surgery;
✕
What they're measuring
1
Responder rate based on 24-hour Holter monitoring.
✕. Patients with serious cardiovascular diseases (such as congestive heart failure, cardiac shock, etc.), cerebrovascular disease, and serious primary 8.diseases such as liver, kidney and hematopoietic system (ALT,AST,BUN 2 times higher than normal ceiling, or Cr higher than the upper limit of normal);
✕. Allergic constitution; the test drug allergy or its ingredients or elements allergy;