The Dose-Effect Relationship Study of Wenxin Granules in the Treatment of Atrial Premature Beats of Deficiency of Both Qi and Yin and Heart Vessel Stasis and Obstruction Syndrome: an Open Label, Randomized, Dose-Response Controlled Trial

Guang'anmen Hospital, China Academy of Chinese Medical Sciences0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

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•1. Accord with the diagnostic criteria of arrhythmia (atrial premature beats);
•2. Accord with the diagnostic criteria of deficiency of both qi and yin and heart vessel stasis and obstruction Syndrome;
•3. The number of premature beat of 24h dynamic electrocardiogram > 360 times/h or > 8640 times/24h;
•4. 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);
•5. Ages 18 to 75 years old ,all genders;
•6. Voluntary subjects and signed the informed consent form.

•1. Serious condition that need to merge other anti-arrhythmic drugs(I,II,III,IV) to treat;
•2. Heart rhythm disorders caused by the factors such as drugs ,electrolyte and acid-base balance disorders;
•3. Merge tardy arrhythmia (including sick sinus syndrome and II degree atrioventricular block);
•4. Removed predisposing factors (such as fatigue, nervousness, mood swings, alcoholism, etc.) the premature beats reduced, while the symptoms significantly relieved;
•5. Patients who have pacemaker implanted or have undergone heart percutaneous coronary intervention (PCI) surgery;
•6. Patients with severe hypotension;
•7. 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);
•8. Allergic constitution; the test drug allergy or its ingredients or elements allergy;
•9. Pregnancy and lactation women ,recent preparation pregnancy;
•10. Patients with chronic alcoholism , drug dependence, mental illness;
•11. Participated in other clinical trials within 3 months.

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