ITMCTR2100004802招募中1 期
Clinical Efficacy Study of Tiaogan Yiqi Dingji Formula on Tachyarrhythmia Based on Psycho-Cardiology
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 85（—）
- 性别
- All
入选标准
- •1. Meet the diagnostic criteria of western medicine for tachyarrhythmia.
- •2. Meet the diagnostic criteria for depression and anxiety.
- •3. Hamilton Depression Scale (HAMD) 17 items score 7-24 points (not including 24 points) or (and) Hamilton Anxiety Scale (HAMA) 14 items score 7-21 points (not including 21 points).
- •4. Comply with TCM diagnostic criteria for heart palpitations (stagnation of liver and qi, syndrome of heart deficiency and timidity).
- •5. Aged 18-85 years.
- •6. There is no restriction on gender.
- •7. Subjects were informed and signed an informed consent form voluntarily.
排除标准
- •1. Transient tachyarrhythmia caused by tobacco, alcohol, coffee, fatigue, infection, fever, anemia, drug-induced electrolyte disturbance (such as low potassium), etc.
- •2. It is hereditary arrhythmia, tachyarrhythmia combined with severe angina pectoris, premature ventricular contractions with a short combined rhythm interval of <300 ms, supraventricular tachycardia with an attack lasting more than 24 hours, new onset atrial flutter, first-diagnosed atrial fibrillation, Pre-excitation combined with atrial fibrillation is accompanied by rapid ventricular rate, continuous ventricular tachycardia (the duration of ventricular tachycardia >= 30s), torsade de pointes type ventricular tachycardia, etc.
- •3. Patients who have non-drug anti-arrhythmic indications such as catheter ablation, electrical cardioversion, and willingness to operate.
- •4. Patients with pacemaker implantation or perioperative period.
- •5. Acute myocardial infarction, severe cardiac insufficiency (NYHA cardiac function class III, IV or LVEF<40%).
- •6. Patients who have taken sedative, hypnotic, anti-anxiety, and antidepressant drugs in the 4 weeks before the trial.
- •7. Suicidal attempts or suicidal tendencies (HMD item 3 score >= 2 points).
- •8. Patients with obvious hemodynamic disorders, syncope, hypotension, and shock.
- •9. Severe mental disorders or other reasons unable to cooperate.
- •10. Patients with severe liver, kidney, hematopoietic system and other primary diseases and dysfunctions.
- •11. Women who are pregnant, preparing to become pregnant or breast-feeding.
- •12. Patients who have participated in other clinical trials in the past 3 months.
研究者
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